20-F
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 20-F
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REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
OR
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þ |
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
For the fiscal year ended March 31, 2005
OR
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o |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number: 1-15182
DR. REDDYS LABORATORIES LIMITED
(Exact name of Registrant as specified in its charter)
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Not Applicable
(Translation of Registrants name
into English)
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ANDHRA PRADESH, INDIA
(Jurisdiction of incorporation or
organization) |
7-1-27, Ameerpet
Hyderabad, Andhra Pradesh 500 016, India
+91-40-23731946
(Address of principal executive offices)
Securities registered or to be registered pursuant to Section 12(b) of the Act:
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Title of Each Class |
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Name of Each Exchange on which Registered |
American depositary shares, each representing one equity share
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New York Stock Exchange |
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Equity Shares*
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New York Stock Exchange |
* Not for trading, but only in connection with the registration of American depositary shares,
pursuant to the requirements of the Securities and Exchange Commission.
Securities registered pursuant to Section 12(g) of the Act: None
Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act: None
Indicate the number of each of the issuers classes of capital or common stock as of the close of
the period covered by the annual report.
76,518,949 Equity Shares
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing
requirements for the past 90 days.
Yes þ No o
Indicate by check mark which financial statement item the registrant has elected to follow.
Item 17 o Item 18 þ
Currency of Presentation and Certain Defined Terms
In this annual report on Form 20-F, references to $ or U.S.$ or dollars or U.S.
dollars are to the legal currency of the United States and references to Rs. or rupees or
Indian rupees are to the legal currency of India. Our financial statements are presented in
Indian rupees and translated into U.S. dollars and are prepared in accordance with United States
Generally Accepted Accounting Principles (U.S. GAAP). References to Indian GAAP are to Indian
Generally Accepted Accounting Principles. References to a particular fiscal year are to our
fiscal year ended March 31 of such year. References to our ADSs are to our American Depositary
Shares.
References to U.S. or United States are to the United States of America, its territories
and its possessions. References to India are to the Republic of India. All references to we,
us, our, DRL, Dr. Reddys or the Company shall mean Dr. Reddys Laboratories Limited. Dr.
Reddys is a registered trademark of Dr. Reddys Laboratories Limited in India. Other trademarks
or trade names used in this annual report on Form 20-F are trademarks registered in the name of Dr.
Reddys Laboratories Limited or are pending before the respective trademark registries.
Except as otherwise stated in this report, all translations from Indian rupees to U.S. dollars
are based on the noon buying rate in the City of New York on March 31, 2005, for cable transfers in
Indian rupees as certified for customs purposes by the Federal Reserve Bank of New York, which was
Rs.43.62 per $1.00. No representation is made that the Indian rupee amounts have been, could have
been or could be converted into U.S. dollars at such a rate or any other rate.
Any discrepancies in any table between totals and sums of the amounts listed are due to
rounding.
Information contained in our website, www.drreddys.com, is not part of this Annual Report and
no portion of such information is incorporated herein.
Forward-looking and Cautionary Statement
IN ADDITION TO HISTORICAL INFORMATION, THIS ANNUAL REPORT CONTAINS CERTAIN FORWARD-LOOKING
STATEMENTS WITHIN THE MEANING OF SECTION 27A OF THE SECURITIES ACT OF 1933, AS AMENDED AND SECTION
21E OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. THE FORWARD-LOOKING STATEMENTS CONTAINED
HEREIN ARE SUBJECT TO CERTAIN RISKS AND UNCERTAINTIES THAT COULD CAUSE ACTUAL RESULTS TO DIFFER
MATERIALLY FROM THOSE REFLECTED IN THE FORWARD-LOOKING STATEMENTS. FACTORS THAT MIGHT CAUSE SUCH A
DIFFERENCE INCLUDE, BUT ARE NOT LIMITED TO, THOSE DISCUSSED IN THE SECTIONS ENTITLED RISK FACTORS
AND OPERATING AND FINANCIAL REVIEW AND PROSPECTS AND ELSEWHERE IN THIS REPORT. READERS ARE
CAUTIONED NOT TO PLACE UNDUE RELIANCE ON THESE FORWARD-LOOKING STATEMENTS, WHICH REFLECT
MANAGEMENTS ANALYSIS ONLY AS OF THE DATE HEREOF. IN ADDITION, READERS SHOULD CAREFULLY REVIEW THE
OTHER INFORMATION IN THIS ANNUAL REPORT AND IN OUR PERIODIC REPORTS AND OTHER DOCUMENTS FILED WITH
THE SECURITIES AND EXCHANGE COMMISSION (SEC) FROM TIME TO TIME.
1
TABLE OF CONTENTS
PART I
ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS
Not applicable.
ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE
Not applicable.
ITEM 3. KEY INFORMATION
3.A. Selected financial data summary of selected consolidated financial data
The selected consolidated financial data should be read in conjunction with the consolidated
financial statements, the related notes and operating and financial review and prospects, which are
included elsewhere in this annual report. The selected consolidated statements of income data for
the five years ended March 31, 2005 and selected consolidated balance sheet data as of March 31,
2001, 2002, 2003, 2004 and 2005 have been derived from our audited consolidated financial
statements and related notes, which have been prepared and presented in accordance with U.S. GAAP.
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Fiscal Year Ended March 31, |
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2001 |
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2002** |
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2003** |
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2004 |
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2005 |
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(Rs. in millions, U.S.$ in thousands, except share data) |
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Convenience |
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translation into |
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U.S.$ |
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(unaudited) |
Income Statement Data: |
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Product sales |
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Rs.10,974.8 |
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Rs.16,408.8 |
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Rs.18,069.8 |
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Rs.20,081.2 |
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Rs.19,126.2 |
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U.S.$438,473 |
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License fees |
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124.8 |
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345.7 |
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7,926 |
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Services |
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89.1 |
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Total revenues |
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10,974.8 |
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16,622.7 |
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18,069.8 |
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20,081.2 |
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19,471.9 |
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446,399 |
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Cost of revenues |
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5,735.8 |
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6,869.0 |
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7,847.6 |
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9,346.1 |
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9,385.8 |
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215,172 |
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Gross profit |
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5,239.0 |
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9,753.7 |
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10,222.2 |
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10,735.1 |
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10,086.1 |
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231,227 |
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Operating expenses, net: |
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Selling, general and administrative expenses |
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2,818.9 |
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3,674.1 |
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5,103.2 |
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6,562.9 |
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6,810.5 |
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156,131 |
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Research and development
expenses, net |
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508.8 |
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742.4 |
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1,411.8 |
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1,991.6 |
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2,803.3 |
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64,267 |
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Amortization expenses |
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482.3 |
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487.7 |
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419.5 |
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382.9 |
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350.0 |
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8,024 |
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Foreign exchange (gain)/loss |
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(62.1 |
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(209.0 |
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70.1 |
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(282.4 |
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488.8 |
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11,206 |
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Total operating expenses |
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3,747.9 |
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4,695.2 |
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7,004.6 |
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8,655.0 |
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10,452.6 |
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239,627 |
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Operating income/(loss) |
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1,491.1 |
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5,058.5 |
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3,217.6 |
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2,080.1 |
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(366.5 |
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(8,400 |
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Equity in loss of affiliates |
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(31.5 |
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(130.5 |
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(92.1 |
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(44.4 |
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(58.1 |
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(1,332 |
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Other (expense) / income, net |
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(387.0 |
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154.5 |
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683.2 |
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504.2 |
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531.6 |
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12,186 |
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Income before income taxes and
minority interest |
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1,072.6 |
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5,082.5 |
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3,808.7 |
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2,540.0 |
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107.0 |
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2,454 |
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Income taxes (expense)/benefit |
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(321.4 |
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(153.8 |
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(398.1 |
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(69.2 |
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94.3 |
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2,161 |
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Minority interest |
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(9.3 |
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(14.9 |
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(6.7 |
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3.4 |
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9.9 |
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228 |
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Net income |
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Rs.741.9 |
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Rs.4,913.8 |
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Rs.3,403.9 |
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Rs.2,474.2 |
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Rs.211.2 |
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U.S.$4,843 |
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Earnings per equity share: |
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Basic |
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Rs.11.74 |
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Rs.64.63 |
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Rs.44.49 |
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Rs.32.34 |
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Rs.2.76 |
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U.S.$0.06 |
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Diluted |
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Rs.11.74 |
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Rs.64.53 |
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Rs.44.49 |
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Rs.32.32 |
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Rs.2.76 |
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U.S.$0.06 |
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Weighted average number of equity shares used in computing
earnings per equity share:* |
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Basic |
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63,177,560 |
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76,027,565 |
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76,515,948 |
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76,513,764 |
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76,518,949 |
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76,518,949 |
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Diluted |
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63,177,560 |
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76,149,568 |
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76,515,948 |
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76,549,598 |
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76,559,801 |
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76,559,801 |
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Cash dividend per share
(excluding dividend tax) |
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Rs.1.75 |
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Rs.7.00 |
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Rs.2.50 |
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Rs.5.00 |
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Rs.5.00 |
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U.S.$0.11 |
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* |
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Each ADR represents one equity share. Historical figures have been adjusted to reflect
the two for one stock split effected in October 2001. |
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Effective as of fiscal 2003, we selected the retroactive modified method of adoption described
in Statement of Financial Accounting Standards No. 148 Accounting for Stock Based Compensation
Transition and Disclosure. Accordingly, the operating results for the year ended March 31, 2002
and 2003, which are the only prior periods impacted, have been modified in accordance with the
retroactive modified method of adoption. |
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Fiscal Year Ended March 31, |
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2001 |
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2002 |
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2003 |
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2004 |
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2005 |
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(Rs. in millions, U.S.$ in thousands, except share data) |
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Convenience |
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translation into |
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U.S.$ |
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(unaudited) |
Other Data: |
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Net cash provided by / (used in): |
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Operating activities |
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Rs.617.1 |
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Rs.4,652.8 |
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Rs.4,366.7 |
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Rs.3,999.2 |
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Rs.2,291.6 |
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U.S.$52,536 |
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Investing activities |
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(689.4 |
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(1,532.9 |
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(1,954.7 |
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(6,506.1 |
) |
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632.9 |
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14,509 |
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Financing activities |
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(87.7 |
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1,421.8 |
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(153 |
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(376.1 |
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1,931.3 |
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44,276 |
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Effect of exchange rate
changes on cash |
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81.5 |
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88.8 |
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(95 |
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(14.2 |
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55.8 |
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1,279 |
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Expenditures on property,
plant and equipment |
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(489.0 |
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(1,090.3 |
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(1,515.7 |
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(2,415.6 |
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(1,749.2 |
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(40,100 |
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Balance Sheet Data: |
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Cash and cash equivalents |
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Rs.478.9 |
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Rs.5,109.4 |
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Rs.7,273.4 |
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Rs.4,376.2 |
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Rs.9,287.9 |
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U.S.$212,927 |
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Working capital |
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795.4 |
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9,518.6 |
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12,023.5 |
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11,103.3 |
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10,770.9 |
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246,926 |
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Total assets |
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11,882.9 |
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18,967.0 |
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23,091.7 |
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26,619.3 |
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29,288.4 |
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671,443 |
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Total long-term debt,
excluding current portion |
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1,003.4 |
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47.0 |
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40.91 |
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31.0 |
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25.1 |
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576 |
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Net Assets |
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5,240.5 |
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15,457.4 |
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18,831.8 |
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21,039.4 |
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20,953.2 |
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480,357 |
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Total stockholders equity |
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5,240.5 |
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15,457.4 |
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18,831.8 |
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21,039.4 |
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20,953.2 |
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480,357 |
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Exchange Rates
The following table sets forth, for the fiscal years indicated, information concerning the
number of Indian rupees for which one U.S. dollar could be exchanged based on the average of the
noon buying rate in the City of New York on the last business day of each month during the period
for cable transfers in Indian rupees as certified for customs purposes by the Federal Reserve Bank
of New York. The column titled Average in the table below is the average of the daily noon buying
rate on the last business day of each month during the year.
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Fiscal Year Ended |
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March 31 |
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Period End |
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Average |
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High |
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Low |
2001 |
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46.85 |
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45.88 |
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46.90 |
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43.70 |
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2002 |
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48.83 |
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|
47.80 |
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48.83 |
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46.88 |
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2003 |
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47.53 |
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48.43 |
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49.07 |
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|
47.53 |
|
2004 |
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43.40 |
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45.96 |
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|
47.46 |
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43.40 |
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2005 |
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43.62 |
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44.86 |
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46.45 |
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|
43.27 |
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The following table sets forth the high and low exchange rates for the previous six
months and are based on the average of the noon buying rate in the City of New York on the last
business day of each month during the period for cable transfers in Indian rupees as certified for
customs purposes by the Federal Reserve Bank of New York:
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Month |
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High |
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Low |
February 2005 |
|
|
43.73 |
|
|
|
43.28 |
|
March 2005 |
|
|
43.70 |
|
|
|
43.44 |
|
April 2005 |
|
|
43.72 |
|
|
|
43.48 |
|
May 2005 |
|
|
43.62 |
|
|
|
43.21 |
|
June 2005 |
|
|
43.71 |
|
|
|
43.44 |
|
July 2005 |
|
|
43.59 |
|
|
|
43.05 |
|
On
August 8, 2005, the noon buying rate in the city of
New York was Rs.43.44 per
U.S. dollar.
3.B. Capitalization and indebtedness
Not applicable.
3.C. Reasons for the offer and use of proceeds
Not applicable.
3.D. Risk factors
3
You should carefully consider all of the information set forth in this Form 20-F and the
following risk factors that we face and that are faced by our industry. The risks below are not the
only ones we face. Additional risks not currently known to us or that we presently deem immaterial
may also affect our business operations. Our business, financial condition or results of operations
could be materially or adversely affected by any of these risks. This Form 20-F also contains
forward-looking statements that involve risks and uncertainties. Our results could materially
differ from those anticipated in these forward-looking statements as a result of certain factors,
including the risks we face as described below and elsewhere. See Forward-Looking Statements.
RISKS RELATING TO OUR COMPANY AND OUR BUSINESS
If our research and development efforts do not succeed, this may restrict our introduction of new
products, which is critical to our business.
Our future results of operations depend, to a significant degree, upon our ability to
successfully commercialize additional products in Active Pharmaceutical Ingredients and
Intermediates, Generics and Formulations, Specialty and Drug Discovery businesses. We must develop,
test and manufacture generic products as well as prove that our generic products are the
bio-equivalent of their branded counterparts. All of our products must meet and continue to comply
with regulatory and safety standards and receive regulatory approvals; we may be forced to withdraw
a product from the market if health or safety concerns arise with respect to such product. The
development and commercialization process, particularly with respect to innovative products, is
both time consuming and costly and involves a high degree of business risk. Our products currently
under development, if and when fully developed and tested, may not perform as we expect, necessary
regulatory approvals may not be obtained in a timely manner, if at all, and we may not be able to
successfully and profitably produce and market such products.
To develop our products pipeline, we commit substantial efforts, funds and other resources to
research and development, both through our own dedicated resources and our collaborations with
third parties. Our ongoing investments in new product launches and research and development for
future products could result in higher costs without a proportionate increase in revenues. Our
overall profitability depends on our ability to continue developing commercially successful
products.
Our dependence on research and development makes it highly important that we recruit and
retain high quality researchers and development specialists. We commit substantial efforts and
funds to this effort. Should we fail in our efforts, this could adversely affect our ability to
continue developing commercially successful products and, thus, our overall profitability.
If we cannot respond adequately to the increased competition we expect to face in the future, we
will lose market share and our profits will go down.
Our products face intense competition from products commercialized or under development, by
competitors in all our business segments based in India and overseas. Many of our competitors have
greater financial resources and marketing capabilities than we do. Some of our competitors,
especially multinational pharmaceutical companies, have greater experience than we do in clinical
testing and human clinical trials of pharmaceutical products and in obtaining regulatory approvals.
Our competitors may succeed in developing technologies and products that are more effective, more
popular or cheaper than any we may develop or license. These developments could render our
technologies and products obsolete or uncompetitive, which would harm our business and financial
results. We believe some of our competitors have broader product ranges, stronger sales forces and
better segment positioning than us, which enables them to compete effectively.
Selling prices of active pharmaceutical ingredients and generic drugs typically decline,
sometimes dramatically, as additional companies receive approvals for a given product and
competition intensifies. To the extent that we succeed in being the first to market a generic
version of a significant product, and particularly if we obtain the 180-day period of market
exclusivity provided under the Hatch-Waxman Act of 1984, as amended, our sales and profit can be
substantially increased in the period following the introduction of such product and prior to a
competitors introduction of the equivalent product or the launch of an authorized generic. Our
ability to sustain our sales and profitability on any product over time is dependent on both the
number of new competitors for such product and the timing of their approvals.
4
Our generics business is also facing increasing competition from brand-name manufacturers, who
do not face any significant regulatory approvals or barriers to entry into the generics market.
These brand-name companies sell generic versions of their products to the market directly or by
acquiring or forming strategic alliances with our competitor generic pharmaceutical companies or by
granting them rights to sell authorized generics. Moreover, brand-name companies continually
seek new ways to delay generic introduction and decrease the impact of generic competition, such as
filing new patents on drugs whose original patent protection is about to expire, developing
patented controlled-release products, changing product claims and product labeling, or developing
and marketing as over-the-counter products those branded products which are about to face generic
competition.
If we cannot maintain our position in the Indian pharmaceutical industry in the future, we may not
be able to attract co-development, outsourcing or licensing partners and may lose market share.
In order to attract multinational corporations into co-development and licensing arrangements,
it is necessary for us to maintain the position of a leading pharmaceutical company in India.
Multinational corporations have been increasing their outsourcing of both active pharmaceutical
ingredients and generic formulations to highly regarded companies that can produce high quality
products at low cost that conform to standards set in developed markets. If we cannot maintain our
current position in the market, we may not be able to attract outsourcing or licensing partners and
may lose market share.
If we fail to comply fully with government regulations applicable to our research and development
activities or regarding the manufacture of our products, it may delay or prevent us from developing
or manufacturing our products.
Our research and development activities are heavily regulated. If we fail to comply fully with
applicable regulations, then there could be a delay in the submission or approval of potential new
products for marketing approval. In addition, the submission of an application to a regulatory
authority does not guarantee that a license to market the product will be granted. Each authority
may impose its own requirements and/or delay or refuse to grant approval, even when a product has
already been approved in another country. In the U.S., as well as many of our international
markets, the approval process for a new product is complex, lengthy and expensive. The time taken
to obtain approval varies by country but generally takes from six months to several years from the
date of application. This registration process increases the cost to us of developing new products
and increases the risk that we will not succeed in selling them successfully.
Also, governmental authorities, including the U.S. Food and Drug Administration (U.S. FDA),
heavily regulate the manufacture of our products. If we or our third party suppliers fail to comply
fully with such regulations, then there could be a government-enforced shutdown of production
facilities, which in turn could lead to product shortages. A failure to comply fully with such
regulations could also lead to a delay in the approval of new products.
If there is a change in government regulations regarding the amount of revenue that we may be able
to derive from a particular product, our revenues may decrease.
Governments throughout the world heavily regulate the marketing of our products. Most
countries also place restrictions on the manner and scope of permissible marketing to physicians
and to other health care professionals. The effect of such regulations may be to limit the amount
of revenue that we may be able to derive from a particular product. In addition, if we fail to
comply fully with such regulations, then civil or criminal actions could be brought against us. In
addition to normal price competition in the market place, the prices of our pharmaceutical products
are restricted by price controls imposed by governments and health care providers in several
countries. Price controls operate differently in different countries and can cause wide variations
in prices between markets. Currency fluctuations can aggravate these differences. The existence of
price controls can limit the revenues we earn from our products.
If a regulatory agency amends or withdraws existing approvals to market our products, this may
cause our revenues to decline.
Regulatory agencies may at any time reassess the safety and efficacy of our products based on
new scientific knowledge or other factors. Such reassessments could result in the amendment or
withdrawal of existing approvals to market our products, which in turn could result in a loss of
revenue, and could serve as an inducement to bring lawsuits against us.
If we are sued by consumers for defects in our products, it could harm our reputation and thus our
profits.
5
Our business inherently exposes us to potential product liability. From time to time, the
pharmaceutical industry has experienced difficulty in obtaining desired amounts of product
liability insurance coverage. Although we have obtained product liability coverage with respect to
products that we manufacture, if any product liability claim not covered by insurance or exceeding
the policy limits were sustained against us, it could harm our business and financial condition.
This risk is likely to increase as we develop our own new-patented products in addition to making
generic versions of drugs that have been in the market for some time.
If we are unable to patent new products and processes, unable to protect our intellectual property
rights or proprietary information, or if we infringe on the patents of others, our business may be
adversely impacted.
Our overall profitability depends, among other things, on our ability to continuously and
timely introduce new generic as well as innovative products. Our success will depend, in part, on
our ability in the future to obtain patents, protect trade secrets, intellectual property rights
and other proprietary information and operate without infringing on the proprietary rights of
others. Our competitors may have filed patent applications, or hold issued patents, relating to
products or processes that compete with those we are developing, or their patents may impair our
ability to successfully develop and commercialize new products.
Our success with our innovative products depends, in part, on our ability to protect our
current and future innovative products and to defend our intellectual property rights. If we fail
to adequately protect our intellectual property, competitors may manufacture and market products
similar to ours. We have been issued patents covering our innovative products and processes and
have filed, and expect to continue to file, patent applications seeking to protect our newly
developed technologies and products in various countries, including the United States. Any existing
or future patents issued to or licensed by us may not provide us with any competitive advantages
for our products or may even be challenged, invalidated or circumvented by competitors. In
addition, such patent rights may not prevent our competitors from developing, using or
commercializing products that are similar or functionally equivalent to our products.
We also rely on trade secrets, unpatented proprietary know-how and continuing technological
innovation that we seek to protect, in part by confidentiality agreements with licensees,
suppliers, employees and consultants. It is possible that these agreements will be breached and we
will not have adequate remedies for any such breach. Disputes may arise concerning the ownership of
intellectual property or the applicability of confidentiality agreements. Furthermore, our trade
secrets and proprietary technology may otherwise become known or be independently developed by our
competitors or we may not be able to maintain the confidentiality of information relating to such
products.
Changes in the regulatory environment may prevent us from utilizing the exclusivity periods that
are important to the success of our generic products.
The policy of the U.S. FDA regarding the award of 180 days of market exclusivity to generic
manufacturers who challenge patents relating to specific products continues to be the subject of
extensive litigation in the United States. The U.S. FDAs current interpretation of the
Hatch-Waxman Act of 1984 is to award 180 days of exclusivity to the first generic manufacturer who
files a Paragraph IV certification under the Hatch-Waxman Act challenging the patent of the branded
product, regardless of whether that generic manufacturer was sued for patent infringement.
The Medicare Prescription Drug, Improvement and Modernization Act of 2003 amended the
Hatch-Waxman Act and provides that the 180-day market exclusivity period provided under the
Hatch-Waxman Act is triggered by the commercial marketing of the product. However, the Medicare
Prescription Drug Act also contains forfeiture provisions, which, if met, will deprive the first
Paragraph IV filer under section 505(j) of the Hatch-Waxman Act of exclusivity. As a result, under
certain circumstances, we may not be able to exploit our 180-day exclusivity period since it may be
forfeited prior to our being able to market the product.
In addition, legal and administrative battles over triggering dates and shared exclusivities
may also prevent us from fully utilizing the exclusivity periods.
If we are unable to defend ourselves in patent challenges, we could be subject to injunctions
preventing us from selling our products, resulting in a decrease in revenues, or we could be
subject to substantial liabilities that would lower our profits.
6
There has been substantial patent related litigation in the pharmaceutical industry concerning
the manufacture, use and sale of various products. In the normal course of business, we are
regularly subject to lawsuits and the ultimate outcome of litigation could adversely affect our
results of operations, financial condition and cash flow. Regardless of regulatory approval,
lawsuits are periodically commenced against us with respect to alleged patent infringements by us,
such suits often being triggered by our filing of an application for governmental approval, such as
a new drug application. The expense of any such litigation and the resulting disruption to our
business, whether or not we are successful, could harm our business. The uncertainties inherent in
patent litigation make it difficult for us to predict the outcome of any such litigation.
If we are unsuccessful in defending ourselves against these suits, we could be subject to
injunctions preventing us from selling our products, resulting in a decrease in revenues, or to
damages, which may be substantial. An injunction or substantial damages resulting from these suits
could adversely effect our consolidated financial position, results of operations or liquidity.
If we elect to sell a generic product prior to the completion of all appellate level patent
litigation, we could be subject to liabilities for damages if a lower court judgment upon which we
are relying is reversed.
At times we seek approval to market generic products before the expiration of patents for
those products, based upon our belief that such patents are invalid, unenforceable, or would not be
infringed by our products. As a result, we often face significant patent litigation. Depending upon
a complex analysis of a variety of legal and commercial factors, if we win a lower court decision
in such patent litigation, we may, in certain circumstances, elect to market a generic product even
though an appeal of the lower court decision is pending. Should we elect to proceed in this manner,
we could face substantial patent liability damages were a higher court to overturn the trial
courts decision.
If we do not maintain and increase our arrangements for overseas distribution of our products, our
revenues and net income could decrease.
We market our products in 86 countries. Our products are marketed in most of these countries
through our subsidiaries as well as joint ventures. As we do not have the resources to market and
distribute our products ourselves in all our export markets, we also market and distribute our
products through third parties by way of marketing and agency arrangements. These arrangements may
be terminated by either party providing the other with notice of termination or when the contract
regarding the arrangement expires. We may not be able to successfully negotiate these third party
arrangements or find suitable joint venture partners in the future. Any of these arrangements may
not be available on commercially reasonable terms. Additionally, our marketing partners may make
important marketing and other commercialization decisions with respect to products we develop
without our input. As a result, many of the variables that may affect our revenues and net income
are not exclusively within our control when we enter into arrangements like these.
If we fail to comply with environmental laws and regulations or face environmental litigation, our
costs may increase or our revenues may decrease.
We may incur substantial costs in compliance with requirements of environmental laws and
regulations. In addition, we may discover currently unknown environmental problems or conditions.
We are subject to significant Indian national and state environmental laws and regulations, which
govern the discharge, emission, storage, handling and disposal of a variety of substances that may
be used in or result from our operations. If any of our plants or the operations of such plants are
shut down, we may continue to incur costs in complying with regulations, appealing any decision to
close our facilities, maintaining production at our existing facilities and continuing to pay labor
and other costs which may continue even if the facility is closed. As a result, our overall
operating expenses may increase and our profits may decrease.
Our equity shares and our ADSs may be subject to market price volatility, and the market price of
our ADSs may decline disproportionately in response to adverse developments that are unrelated to
our operating performance.
Market prices for the securities of Indian pharmaceutical companies, including our own, have
historically been highly volatile, and the market has from time to time experienced significant
price and volume fluctuations that are unrelated to the operating performance of particular
companies. Factors such as the following can have an adverse effect on the market price of our ADSs
and equity shares:
|
° |
|
general market conditions, |
7
|
° |
|
speculative trading in our shares and ADSs, |
|
|
° |
|
changes in the weight given to our shares in Stock Exchange, Mumbai (BSE) and National
Stock Exchange (NSE) indices, and |
|
|
° |
|
developments relating to our peer companies in the pharmaceutical industry. |
If the world economy is affected due to terrorism or wars, it may adversely affect our business and
results of operations.
Several areas of the world have experienced terrorist acts and retaliatory operations
recently. If the overall economy of the world is affected by such acts, our business and results of
operations may be adversely affected as a consequence.
If we have difficulty in identifying acquisition candidates, obtaining satisfactory acquisition
financing or integrating companies that we merge with or acquire, our business may be harmed.
We may acquire or make strategic investments in complementary businesses or products, or enter
into strategic partnerships or alliances with third parties in order to enhance our business. It is
possible that we may not identify suitable acquisition, strategic investment or strategic
partnership candidates, or if we do identify suitable candidates, we may not complete those
transactions on terms commercially acceptable to us or at all. Our acquisition strategy may
require us to obtain additional debt or equity financing, resulting in additional leverage, or
increased debt obligations as compared to equity, and dilution of ownership. We may not be able to
finance acquisitions on terms satisfactory to us. The inability to identify suitable acquisition
targets or investments or the inability to complete such transactions may affect our
competitiveness and our growth prospects.
Acquisitions may involve a number of risks, including diversion of managements attention,
failure to retain key acquired personnel and clients, unanticipated events or circumstances, legal
liabilities and amortization of acquired intangible assets, some or all of which could harm our
results of operations and financial condition. Our inability to successfully integrate companies
that we have acquired or merged with, or companies that we acquire or merge with in the future,
could harm our business.
Our principal shareholders control us and, if they take actions that are not in your best
interests, the value of your investment in our ADSs may be harmed.
Our full time directors together with members of their immediate families, in the aggregate,
beneficially own 26.3% of our issued shares. As a result, these people, acting in concert, are
likely to have the ability to exercise significant control over most matters requiring approval by
our shareholders, including the election and removal of directors and significant corporate
transactions. This control by these directors and their family members could delay, defer or
prevent a change in control of us, impede a merger, consolidation, takeover or other business
combination involving us, or discourage a potential acquirer from making a tender offer or
otherwise attempting to obtain control of us, even if that was in our best interest. As a result,
the value of your ADSs may be adversely affected or you might be deprived of a potential
opportunity to sell your ADSs at a premium.
If we improperly handle any of the dangerous materials used in our business and accidents result,
we could face significant liabilities that would lower our profits.
We handle dangerous materials including explosive, toxic and combustible materials like sodium
azide, acrolein and acetyl chloride. If improperly handled or subjected to the wrong conditions,
these materials could hurt our employees and other persons, cause damage to our properties and harm
the environment. This, in turn, could subject us to significant litigation, which could lower our
profits in the event we were found liable.
If there is delay and/or failure in supplies of materials, services and finished goods from third
parties, it may adversely affect our business and results of operations.
In some of our key business operations, such as the manufacture, formulation and packaging of
products, we rely on third parties for the timely supply of specified raw materials, equipment,
contract manufacturing, formulation or packaging services and maintenance services. Although we
actively manage these third party relationships to ensure continuity of supplies on time and to our
required specifications, some events beyond our control could result in the complete or partial
8
failure of supplies or in supplies not being delivered on time. Any such failure could
adversely affect our results of business and results of operations.
If we do not effectively manage our operations in our foreign subsidiaries and review equity
investees, these operations may incur losses or otherwise adversely affect our business and results
of operations.
Currently, we operate our business through subsidiaries and equity investees in other
countries. Because of our limited experience in operating subsidiaries and reviewing equity
investees outside of India, we are subject to additional risks related to our international
expansion strategy, including risks related to complying with a wide variety of national and local
laws, restrictions on the import and export of certain intermediates, drugs, technologies and
multiple and possibly overlapping tax structures. In addition, we may face competition in other
countries from companies that may have more experience with operations in such countries or with
international operations generally. We may also face difficulties integrating new facilities in
different countries into our existing operations, as well as integrating employees that we hire in
different countries into our existing corporate culture. If we do not effectively manage our
operations in these subsidiaries and review equity investees effectively we may lose money in these
countries and it may adversely affect our business and results of operations.
Fluctuations in exchange rates may adversely affect our business and results of operations.
Our principal subsidiaries are located in the United States, United Kingdom and Russia and
each has significant local operations. A significant portion of our revenues are in other
currencies, especially the U.S. dollar, Euro and Pound sterling, while a significant portion of our
costs are in Indian rupees. As a result, if the value of the Indian rupee appreciates relative to
these other currencies, our revenues will decrease.
If there is a change in tax regulations, it may increase our tax liabilities and thus adversely
affect our financial results.
Currently, we enjoy various tax benefits and exemptions under Indian tax laws. Any changes in
these laws, or their application in matters such as tax exemption on export income and transfer
pricing, may increase our tax liabilities and thus adversely affect our financial results.
If there is a change in accounting standards, it may affect our reported results of operations.
New or revised accounting standards and rules promulgated from time to time by United States
or Indian accounting standard boards may significantly affect our reported results of operations.
Any change in accounting standards may affect our reported results of operation. The preparation
of financial statements in accordance with U.S.GAAP involves making estimates, judgments and
assumptions that affect reported amounts of assets (including intangible assets), liabilities and
related reserves, revenues, expenses and income. Estimates, judgments and assumptions are
inherently subject to change in the future, and any such changes could result in corresponding
changes to the amounts of assets (including goodwill and other intangible assets), liabilities,
revenues, expenses and income. Any such changes could have a material adverse effect on our
financial position and results of operations.
If we were to experience a supply interruption, we might be unable to meet the active
pharmaceutical ingredients needs of our generics and formulations segments, and our needs might
conflict with those of our active pharmaceutical ingredients customers.
Many of the active pharmaceutical ingredients and formulations that we manufacture, distribute
and sell are dependent on highly specialized raw materials. In the event that we experience a
shortage in our supply of raw materials, we might be unable to fulfill all of the active
pharmaceutical ingredients needs of our generics and formulations segments, which could result in a
loss of production capacity for these segments. In addition, this could result in a conflict
between the active pharmaceutical ingredients needs of our generics and formulations segments and
the needs of customers of our active pharmaceutical ingredients segment, some of whom are also our
competitors in the formulations segment. In either case, we could potentially lose business from
adversely affected customers and, we could be subjected to lawsuits.
Compliance with new and changing corporate governance and public disclosure requirements diverts
management time and attention from revenue-generating activities to compliance activities, which
may adversely affect our business.
9
Changing laws, regulations and standards relating to accounting, corporate governance and
public disclosure, including the Sarbanes-Oxley Act of 2002, new SEC regulations, NYSE rules,
Securities and Exchange Board of India rules and Indian stock market listing regulations, are
creating uncertainty for companies like ours. These new or changed laws, regulations and standards
may lack specificity and are subject to varying interpretations. Their application in practice may
evolve over time as new guidance is provided by regulatory and governing bodies. This could result
in continuing uncertainty regarding compliance matters and higher costs of compliance as a result
of ongoing revisions to such governance standards. We are committed to maintaining high standards
of corporate governance and public disclosure, and our efforts to comply with evolving laws,
regulations and standards in this regard have resulted in, and are likely to continue to result in,
increased general and administrative expenses and a diversion of management time and attention from
revenue-generating activities to compliance activities. The new laws, regulations and standards
regarding corporate governance may make it more difficult for us to obtain director and officer
liability insurance. Further, our board members, chief executive officer and chief financial
officer could face an increased risk of personal liability in connection with their performance of
duties. As a result, we may face difficulties attracting and retaining qualified board members and
executive officers, which could harm our business.
Employees are vital for the continuous growth of our business
The single greatest advantage of any company is its people. Their skills and intellect are critical
to the successful achievement of our business goals and objectives. If we are unable to retain our
key personnel, it may adversely affect our business operations.
RISKS RELATING TO INVESTMENTS IN INDIAN COMPANIES
We are an Indian company and a substantial part of our operations are conducted, and most of
our assets are located, in India. In addition, approximately 34.4% of our total revenues for fiscal
2005 were derived from sales in India. As a result, the following additional risk factors apply.
A slowdown in economic growth in India may adversely affect our business and results of operations.
Our performance and the quality and growth of our business are necessarily dependent on the
health of the overall Indian economy. The Indian economy has grown significantly over the past few
years. Any future slowdown in the Indian economy could harm us, our customers and other contractual
counterparties. In addition, the Indian economy is in a state of transition. The share of the
services sector of the economy is rising while that of the industrial, manufacturing and
agricultural sector is declining. It is difficult to gauge the impact of these fundamental economic
changes on our business.
A significant change in the Indian government or in its economic liberalization and deregulation
policies may adversely affect the Indian economy, the health of which our business depends upon.
The Indian government has traditionally exercised and continues to exercise a dominant
influence over many aspects of the economy. Any significant change in its economic policies could
have a significant effect on private-sector entities, including us, and on market conditions and
prices of Indian securities, including our shares and our ADSs. Indias trade relationships with
other countries can also influence Indian economic conditions, which in turn can affect our
business.
If communal disturbances or riots erupt in India, or if regional hostilities increase, this would
adversely affect the Indian economy, the health of which our business depends upon.
India has experienced communal disturbances, terrorist attacks and riots during recent years.
If such disturbances continue or are exacerbated, our operational, sales and marketing activities
may be adversely affected. Additionally, India has from time to time experienced hostilities with
neighboring countries. The hostilities have continued sporadically. The hostilities between India
and Pakistan are particularly threatening, because both India and Pakistan are nuclear powers.
Hostilities and tensions may occur in the future and on a wider scale. These hostilities and
tensions could lead to political or economic instability in India and harm our business operations,
our future financial performance and the price of our shares and our ADSs.
10
If inflation continues to rise in India, we may not be able to increase the prices of our products
in order to pass the costs along to our customers and our profits may decline.
According to the monthly report for April 2005 released by the Indian Ministry of Finance, the
annual inflation rate in India, as measured by the benchmark wholesale price index (Base
1993-94=100), was6.7% in fiscal 2005 as compared with 5.5% in fiscal 2004 The rate of inflation
may continue to rise. We may not be able to pass these costs on to our customers by increasing the
price we charge for our products. If this occurs, our profits may decline.
If environmental conditions in India including drought, floods and earthquakes, affect our main
facilities, our revenues could decline.
Our main facilities are situated around Hyderabad, in India. This region has experienced
earthquakes, floods and droughts in the past and has experienced droughts in recent years In the
event of a drought so serious that the drinking water in the region is limited, the government
could cut the supply of water to all industries including our facilities and this would adversely
affect our production operations and reduce our revenues. Even if we take precautions to provide
back-up support in the event that a natural disaster occurs in parts of India affecting our main
facilities, environmental conditions may affect our facilities, harming production and ultimately
our business.
Wage pressures in India may increase our costs and reduce our profit margins.
Wage costs in India have historically been significantly lower than wage costs in developed
countries and have been one of our competitive strengths. However, wage increases in India may
increase our costs, reduce our profit margins and adversely affect our business and results of
operations.
Indian law imposes certain restrictions that limit a holders ability to transfer the equity shares
obtained upon conversion of ADSs and repatriate the proceeds of such transfer, which may cause our
ADSs to trade at a premium or discount to the market price of our equity shares.
Under certain circumstances, the Reserve Bank of India must approve the sale of equity
shares underlying ADSs by a non-resident of India to a resident of India. The Reserve Bank of India
has given general permission to effect sales of existing shares or convertible debentures of an
Indian company by a resident to a non-resident, subject to certain conditions, including the price
at which the shares may be sold. Additionally, except under certain limited circumstances, if an
investor seeks to convert the rupee proceeds from a sale of equity shares in India into foreign
currency and then repatriate that foreign currency from India, he or she will have to obtain an
additional approval from the Reserve Bank of India for each such transaction. Required approval
from the Reserve Bank of India or any other government agency may not be obtained on terms
favorable to a non-resident investor or at all.
There are limits and conditions to the deposit of shares into the ADS facility.
Indian legal restrictions may limit the supply of ADSs. The only way to add to the supply of
ADSs will be through a primary issuance because the depositary will not be permitted to accept
deposits of outstanding shares and issue ADSs representing those shares. However, an investor in
ADSs who surrenders an ADS and withdraws shares will be permitted to redeposit those shares in the
depositary facility in exchange for ADSs. In addition, an investor who has purchased shares in the
Indian market will be able to deposit them in the ADS program, but only in a number that does not
exceed the number of underlying shares that have been withdrawn from and not re-deposited into the
depositary facility. Moreover, there are restrictions on foreign institutional ownership of shares
as opposed to ADSs.
There may be less company information available in Indian securities markets than securities
markets in developed countries.
There is a difference between the level of regulation and monitoring of the Indian securities
markets over the activities of investors, brokers and other participants, as compared to the level
of regulation and monitoring of markets in the United States and other developed economies. The
Securities and Exchange Board of India is responsible for improving disclosure and other regulatory
standards for the Indian securities markets. The Securities and Exchange Board of India has issued
regulations and guidelines on disclosure requirements, insider trading and other matters. There
may, however, be less publicly available information about Indian companies than is regularly made
available by public companies in developed countries, which could affect the market for our equity
shares.
11
Indian stock exchange closures, broker defaults, settlement delays, and Indian government
regulations on stock market operations could affect the market price and liquidity of our equity
shares.
The Indian securities markets are smaller than the securities markets in the United States and
Europe and have experienced volatility from time to time. The regulation and monitoring of the
Indian securities market and the activities of investors, brokers and other participants differ, in
some cases significantly, from those in the United States and some European countries. Indian stock
exchanges have at times experienced problems, including temporary exchanges closures, broker
defaults and settlement delays and if similar problems were to recur, they could affect the market
price and liquidity of the securities of Indian companies, including our shares. Furthermore, any
change in Indian government regulations on stock markets could affect the market price and
liquidity of our shares
Financial instability in other countries, particularly emerging market countries in Asia, could
affect our business and the price and liquidity of our shares and our ADSs.
The Indian markets and the Indian economy are influenced by economic and market conditions in
other countries, particularly emerging market countries in Asia. Although economic conditions are
different in each country, investors reactions to developments in one country can have adverse
effects on the securities of companies in other countries, including India. Any worldwide financial
instability or any loss of investor confidence in the financial systems of Asian or other emerging
markets could increase volatility in Indian financial markets or adversely affect the Indian
economy in general. Either of these results could harm our business, our future financial
performance and the price of our shares and ADSs.
If you are not able to exercise preemptive rights available to other shareholders, your investment
in our securities may be diluted.
A company incorporated in India must offer its holders of shares preemptive rights to
subscribe and pay for a proportionate number of shares to maintain their existing ownership
percentages prior to the issuance of any shares, unless these rights have been waived by at least
75.0% of the companys shareholders present and voting at a shareholders general meeting. U.S.
investors in our ADSs may be unable to exercise preemptive rights for the shares underlying our
ADSs unless a registration statement under the Securities Act of 1933 is effective with respect to
the rights or an exemption from the registration requirements of the Securities Act is available.
Our decision to file a registration statement will depend on the costs and potential liabilities
associated with a registration statement as well as the perceived benefits of enabling U.S.
investors in our ADSs to exercise their preemptive rights and any other factors we consider
appropriate at the time. We might choose not to file a registration statement under these
circumstances. If we issue any of these securities in the future, such securities may be issued to
the depositary, which may sell them in the securities markets in India for the benefit of the
investors in our ADSs. We cannot assure you as to the value, if any, the depositary would receive
upon the sale of these securities. To the extent that you are unable to exercise preemptive rights,
your proportional interests in us would be reduced.
ITEM 4. INFORMATION ON OUR COMPANY
4.A. History and development of our company
Dr. Reddys Laboratories Limited was incorporated in India under the Companies Act, 1956, by
its promoter, Dr. K. Anji Reddy as a Private Limited Company on February 24, 1984. We were
converted to a Public Limited Company on December 6, 1985 and listed on the Indian Stock Exchanges
in August 1986 and on the New York Stock Exchange on April 11, 2001. We are registered with the
Registrar of Companies, Andhra Pradesh, Hyderabad, India as Company No. 01-4507. Our registered
office is situated at 7-1-27, Ameerpet, Hyderabad 500 016, Andhra Pradesh, India and the
telephone number of our registered office is +91-40-23731946. The name and address of our
registered agent in the United States is Dr. Reddys Laboratories, Inc., 200 Somerset Corporate
Boulevard (Bldg II), Bridgewater, New Jersey 08807.
Key business developments:
In April 2004, we acquired Trigenesis Therapeutics, Inc., a U.S. based privately owned
dermatology company. This acquisition provided us with access to certain products and proprietary
drug delivery technology platforms for developing a pipeline of differentiated specialty products
in the dermatology prescription segment. The total consideration for this
12
transaction was U.S.$11.0 million. In connection with this transaction, we assumed certain
future milestone and royalty payment obligations of Trigenesis Therapeutics, Inc.
In November 2004, Novo Nordisk decided to terminate further clinical development of
balaglitazone (DRF 2593), which is an insulin sensitizer that acts as a partial Peroxisome
Proliferator Activated Receptor (PPAR) gamma agonist and is an oral treatment for patients with
type 2 diabetes. Novo Nordisk decided to terminate further clinical development of balaglitazone,
as the preclinical results did not suggest a sufficient competitive advantage for balaglitazone
compared to similar marketed products within this therapeutic category. We licensed this molecule
to Novo Nordisk in 1997.
Pursuant to an agreement entered into with Novartis Pharma AG (Novartis), we agreed to
provide Novartis with an exclusive license to develop, promote, distribute, market and sell certain
products to be further developed into drugs for the treatment of specified diseases. Pursuant to
the terms of this agreement, during fiscal 2002, we received Rs.235,550 (U.S.$5 million) as an
up-front license fee. As the up-front license fee did not represent the culmination of a separate
earning process, the up-front license fee had been deferred to be recognized in accordance with our
accounting policy proportionately upon the receipt of stated milestones. Under the terms of the
agreement, Novartis had the rights for an additional dual acting insulin sensitiser compound (the
backup compound). In June 2003, Novartis decided to discontinue further development of the
primary compound licensed from us but continued its collaboration with us for the backup compound.
The agreement with Novartis for the further development of the backup compound expired on May 30,
2004 and, accordingly, we recognized the amount of Rs.235.6 million as revenue during the three
months ended June 30, 2004.
In February 2005, we initiated Phase I clinical trials for our cardiovascular drug candidate
RUS 3108. The clinical trials are being conducted in Belfast, Ireland and will explore the safety
and pharmacokinetic profiles of this drug candidate in humans. This is the first time we are
testing a drug in Europe. RUS 3108 is being developed for the treatment of atherosclerosis, the
major cause of cardiovascular disorders such as heart attacks and stroke. Cardiovascular disease is
a leading cause of death worldwide. To our knowledge, there are currently no drugs on the market
that directly treat atherosclerosis.
During fiscal 2005, we entered into an agreement with I-VEN Pharma Capital Limited (I-VEN)
for the joint development and commercialization of generic drug products. The agreement gives I-VEN
the right to fund up to fifty percent of the project costs (development, registration and legal
costs) related to these products and the related U.S. Abbreviated New Drug Applications (ANDA)
filed or to be filed in 2004-05 and 2005-06, subject to a maximum funding right of U.S.$56.0
million. The terms of the arrangement do not require us to repay the funds or purchase I-VENs
interest in the event that we are not able to develop or commercialize one or more of the products
subject to this agreement. However, upon successful commercialization of these products, we will
be required to pay I-VEN a royalty on net sales for a period of 5 years from the date of
commercialization of each product, which royalty rate is determined by the development,
registration and legal costs that we actually incur to commercialize such product. The first
tranche advanced by I-VEN of U.S.$22.5 million (Rs.985.4 million) was received on March 28, 2005.
I-VEN has an option to further invest U.S.$33.5 million (Rs.1,465.5 million) by March 31, 2006. The
amounts received from I-VEN will be recognized in the income statement as a credit to research and
development expenses upon completion of specific milestones as detailed in the agreement.
Accordingly, an amount of U.S.$2.2 million (Rs.96.2 million) has been recognized in the current
year representing the proportionate costs relating to the completion of specified ANDA filings.
During fiscal 2005, we filed 13 ANDAs, including 6 Paragraph IVs. As of March 31, 2005, we had
45 ANDAs pending at the U.S. FDA. During fiscal 2005, we filed 9 Drug Master Files (DMFs) with
the U.S. FDA. We also filed 306 dossiers in various international markets.
On March 24, 2005, we completed the sale of our remaining 49% equity stake in Compact Electric
Limited for Rs.82,000. We had previously sold 51% of our equity stake in this company in fiscal
2004.
As of March 31, 2005, the capital work-in-progress was Rs.568.0 million, primarily in India.
Our capital work-in-progress is financed entirely through internally generated funds. We are in the
process of expanding our existing formulations and active pharmaceutical ingredients and
intermediates (API) facilities. We are in the process of establishing new facilities in our
formulations and critical care businesses. Expenditures related to specific assets incurred during
the project implementation period are carried as capital work-in-progress. These will be
transferred to specific assets as and when these assets are available for use.
13
During fiscal 2004 and fiscal 2005, no third party made any public takeover offers in respect
of our shares and we did not make any public offers to takeover any other company.
4.B. Business overview
We are an emerging global pharmaceutical company with proven research capabilities. We produce
active pharmaceutical ingredients and finished dosage forms and biotechnology products and market
them globally, with a focus on India, the United States, Europe and Russia. We conduct basic
research in the areas of cancer, diabetes, cardiovascular disease, inflammation and bacterial
infection.
Our revenues for fiscal 2005 were Rs.19,471.9 million (U.S.$446.4 million). We derived 34.4%
of these revenues from sales in India, 22.3% from the United States and Canada (North America),
14.3% from Russia and other countries of the former Soviet Union, 14.7% from Europe and 14.3% from
other countries. Our net income for fiscal 2005 was Rs.211.2 million (U.S.$4.8 million).
OUR STRATEGY
Our vision is to build a discovery-led global pharmaceutical company, with a strong pipeline
of generics as well as innovative products. Our core businesses of active pharmaceutical
ingredients and intermediates and formulations are well established with a track record of growth
and profitability. In our generics business, we are building a pipeline of products that will help
us drive growth in the medium-term. In addition, we are focusing our investments on innovation led
businesses, including specialty pharmaceuticals and drug discovery. These businesses, while being
investment intensive and with long lead times, have the potential to provide significant growth as
well as sustained revenues and profitability for much longer periods due to patent protected
franchises. As a result, we believe that over the next few years, our fully established core
businesses will fund the growth of our generics business and the establishment of our innovation
businesses.
OUR PRINCIPAL AREAS OF OPERATIONS
The following table shows our revenues and percentage of total revenues of our formulations,
active pharmaceutical ingredients and intermediates, generics, critical care and biotechnology and
drug discovery segments for fiscal 2003, 2004 and 2005 respectively:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal Year Ended March 31, |
Segment |
|
2003 |
|
2004 |
|
2005 |
|
|
(Rs. in millions, U.S.$ in thousands) |
Formulations |
|
|
Rs.6,860.4 |
|
|
|
38.0 |
% |
|
|
Rs.7,507.5 |
|
|
|
37.4 |
% |
|
|
Rs.7,822.9 |
|
|
|
40.2 |
% |
|
|
U.S.$179,342.3 |
|
Active pharmaceutical |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ingredients and intermediates |
|
|
6,340.7 |
|
|
|
35.1 |
|
|
|
7,628.5 |
|
|
|
38.0 |
|
|
|
6,944.5 |
|
|
|
35.7 |
|
|
|
159,205.1 |
|
Generics |
|
|
4,284.2 |
|
|
|
23.7 |
|
|
|
4,337.5 |
|
|
|
21.6 |
|
|
|
3,577.4 |
|
|
|
18.4 |
|
|
|
82,013.3 |
|
Critical care and biotechnology |
|
|
428.2 |
|
|
|
2.4 |
|
|
|
411.0 |
|
|
|
2.0 |
|
|
|
527.1 |
|
|
|
2.7 |
|
|
|
12,084.1 |
|
Drug discovery |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
288.4 |
|
|
|
1.4 |
|
|
|
6,611.2 |
|
Other |
|
|
156.3 |
|
|
|
0.8 |
|
|
|
196.7 |
|
|
|
1.0 |
|
|
|
311.6 |
|
|
|
1.6 |
|
|
|
7,143.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
Rs.18,069.8 |
|
|
|
100.0 |
% |
|
|
Rs.20,081.2 |
|
|
|
100.0 |
% |
|
|
Rs.19,471.9 |
|
|
|
100.0 |
% |
|
|
U.S.$446,399.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Formulations Segment
Formulations, also referred to as branded finished dosages, are finished pharmaceutical
products ready for consumption by the patient. Branded means we package the formulations for sale
under our brand name. We sell branded formulations in India and other emerging markets.
Formulations accounted for 40.2% of our revenues in fiscal 2005.
We export our branded formulations to over 36 countries worldwide. Our major markets in this
segment are India, Russia and other countries of the former Soviet Union, Central Eastern Europe,
Southeast Asian countries and Latin America. We have also expanded our presence in emerging
markets, such as Romania, Albania, South Africa, Peru and in the Middle East region. We have
progressively increased the number of countries in which we market our formulations by registering
our products in various markets around the world. During fiscal 2005, we filed 306 new product
dossiers in various countries around the world. Between March 31, 2005 and June 30, 2005, we filed
an additional 159 new product
14
dossiers in various countries around the world.
The following table sets forth formulations revenues by geographic area for fiscal 2003, 2004
and 2005 respectively:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal Year Ended March 31, |
|
|
2003 |
|
2004 |
|
2005 |
Country |
|
Revenues |
|
% Total(1) |
|
Revenues |
|
% Total(1) |
|
Revenues |
|
% Total(1) |
|
|
(in millions) |
|
|
|
|
|
(in millions) |
|
|
|
|
|
(in millions) |
|
|
|
|
India |
|
Rs. |
4,303.2 |
|
|
|
62.7 |
% |
|
Rs. |
4,729.3 |
|
|
|
63.0 |
% |
|
Rs. |
4,360.2 |
|
|
U.S.$ |
100.0 |
|
|
|
55.7 |
% |
Russia |
|
|
1,660.8 |
|
|
|
24.2 |
|
|
|
1,781.8 |
|
|
|
23.7 |
|
|
|
2,107.2 |
|
|
|
48.3 |
|
|
|
26.9 |
|
Ukraine |
|
|
157.1 |
|
|
|
2.3 |
|
|
|
184.2 |
|
|
|
2.5 |
|
|
|
257.8 |
|
|
|
5.9 |
|
|
|
3.3 |
|
Kazakhstan |
|
|
145.5 |
|
|
|
2.1 |
|
|
|
154.5 |
|
|
|
2.1 |
|
|
|
183.7 |
|
|
|
4.2 |
|
|
|
2.3 |
|
Belarus |
|
|
106.8 |
|
|
|
1.6 |
|
|
|
100.2 |
|
|
|
1.3 |
|
|
|
140.1 |
|
|
|
3.2 |
|
|
|
1.8 |
|
Romania |
|
|
55.8 |
|
|
|
0.8 |
|
|
|
82.0 |
|
|
|
1.1 |
|
|
|
102.6 |
|
|
|
2.4 |
|
|
|
1.3 |
|
Venezuela |
|
|
63.0 |
|
|
|
0.9 |
|
|
|
70.4 |
|
|
|
0.9 |
|
|
|
96.0 |
|
|
|
2.2 |
|
|
|
1.2 |
|
Vietnam |
|
|
62.4 |
|
|
|
0.9 |
|
|
|
56.7 |
|
|
|
0.8 |
|
|
|
73.5 |
|
|
|
1.7 |
|
|
|
0.9 |
|
Myanmar |
|
|
45.6 |
|
|
|
0.7 |
|
|
|
47.6 |
|
|
|
0.6 |
|
|
|
68.1 |
|
|
|
1.6 |
|
|
|
0.9 |
|
Sri Lanka |
|
|
49.7 |
|
|
|
0.7 |
|
|
|
62.3 |
|
|
|
0.8 |
|
|
|
67.0 |
|
|
|
1.5 |
|
|
|
0.9 |
|
Others |
|
|
210.5 |
|
|
|
3.1 |
|
|
|
238.5 |
|
|
|
3.2 |
|
|
|
366.6 |
|
|
|
8.4 |
|
|
|
4.7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
Rs. |
6,860.4 |
|
|
|
100.0 |
% |
|
Rs. |
7,507.5 |
|
|
|
100.0 |
% |
|
Rs. |
7,822.9 |
|
|
U.S.$ |
179.3 |
|
|
|
100.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Refers to our revenues from formulations sales in the applicable country expressed as a
percentage of our total revenues from formulations sales throughout the world. |
Emerging markets India and Russia
India. Our revenues from sales of formulations in India were 55.7% of our total formulations
sales in fiscal 2005. In India, our formulations business focuses mainly on the therapeutic
categories of cardiovascular, diabetes management, gastro-intestinal and pain management. As of
March 31, 2005, we had a total of 117 brands. Our top ten brands together accounted for 50.7% of
our formulations revenues in India in fiscal 2005. Our sales of formulations in India declined 7.8%
in fiscal 2005 as compared to the industry average growth of 4.2% according to Operations Research
Group International Medical Statistics (ORG IMS), a market research firm, in its March Moving
Annual Total report for the 12-month period ending March 2005. This decline was primarily due to
the slowdown in the growth of our key brands as well as inventory reduction by stockists, retailers
and other trade channels due to uncertainty relating to the implementation of the new value added
tax system in India. According to ORG IMS, as of March 2005, we had 32 brands that were ranked
either first or second in terms of sales in India in their respective product categories. According
to the Center for Marketing and Advertising Research Consultancy (CMARC) report for the period
November 2004 to February 2005, which measures doctors prescriptions, we were the seventh most
prescribed company in India.
New product launches during fiscal 2005 accounted for 5.8% of our revenues from sales of
formulations in India. Key product launches included Retoz, our brand of etoricoxib, and Dutas, our
brand of dutasteride. According to the ORG IMS March Moving Annual Total report for the 12 month
period ended March 2005, we are ranked fourth among Indian pharmaceutical companies in terms of the
revenues derived from new product sales launched in the previous 24 months.
15
The following table provides a summary of our sales in India in our therapeutic categories for
fiscal 2003, 2004 and 2005 respectively:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal Year Ended March 31, |
|
|
2003 |
|
2004 |
|
2005 |
|
|
Number |
|
|
|
|
|
|
|
|
|
Number |
|
|
|
|
|
|
|
|
|
Number |
|
|
|
|
Therapeutic |
|
of our |
|
|
|
|
|
|
|
|
|
of our |
|
|
|
|
|
|
|
|
|
of our |
|
|
|
|
Category (1) |
|
Products |
|
Revenues |
|
% (2) |
|
Products |
|
Revenues |
|
% (2) |
|
Products(3) |
|
Revenues |
|
% (2) |
|
|
|
|
|
|
(in millions) |
|
|
|
|
|
|
|
|
|
(in millions) |
|
|
|
|
|
|
|
|
|
(in millions) |
|
|
|
|
Cardiovascular |
|
|
33 |
|
|
|
Rs.768.8 |
|
|
|
17.9 |
% |
|
|
35 |
|
|
|
Rs.928.3 |
|
|
|
19.6 |
% |
|
|
35 |
|
|
|
Rs.937.6 |
|
|
|
U.S.$21.5 |
|
|
|
21.5 |
% |
Gastro-intestinal |
|
|
43 |
|
|
|
846.2 |
|
|
|
19.7 |
|
|
|
36 |
|
|
|
1,015.0 |
|
|
|
21.5 |
|
|
|
38 |
|
|
|
902.0 |
|
|
|
20.7 |
|
|
|
20.7 |
|
Pain management |
|
|
32 |
|
|
|
823.3 |
|
|
|
19.1 |
|
|
|
36 |
|
|
|
783.6 |
|
|
|
16.6 |
|
|
|
19 |
|
|
|
713.7 |
|
|
|
16.4 |
|
|
|
16.4 |
|
Anti-infectives |
|
|
39 |
|
|
|
433.5 |
|
|
|
10.1 |
|
|
|
30 |
|
|
|
439.1 |
|
|
|
9.3 |
|
|
|
19 |
|
|
|
324.1 |
|
|
|
7.4 |
|
|
|
7.4 |
|
Diabetes Management |
|
|
17 |
|
|
|
274.8 |
|
|
|
6.4 |
|
|
|
23 |
|
|
|
301.1 |
|
|
|
6.4 |
|
|
|
21 |
|
|
|
297.9 |
|
|
|
6.8 |
|
|
|
6.8 |
|
Neutraceuticals |
|
|
21 |
|
|
|
371.7 |
|
|
|
8.6 |
|
|
|
20 |
|
|
|
301.3 |
|
|
|
6.4 |
|
|
|
16 |
|
|
|
243.9 |
|
|
|
5.6 |
|
|
|
5.6 |
|
Dermatology |
|
|
19 |
|
|
|
156.9 |
|
|
|
3.6 |
|
|
|
19 |
|
|
|
206.1 |
|
|
|
4.4 |
|
|
|
16 |
|
|
|
206.5 |
|
|
|
4.7 |
|
|
|
4.7 |
|
Respiratory |
|
|
23 |
|
|
|
207.9 |
|
|
|
4.8 |
|
|
|
19 |
|
|
|
206.6 |
|
|
|
4.4 |
|
|
|
14 |
|
|
|
177.5 |
|
|
|
4.1 |
|
|
|
4.1 |
|
Dental |
|
|
20 |
|
|
|
131.4 |
|
|
|
3.1 |
|
|
|
23 |
|
|
|
173.2 |
|
|
|
3.7 |
|
|
|
22 |
|
|
|
177.3 |
|
|
|
4.1 |
|
|
|
4.1 |
|
Urology |
|
|
9 |
|
|
|
83.5 |
|
|
|
1.9 |
|
|
|
10 |
|
|
|
96.6 |
|
|
|
2.0 |
|
|
|
17 |
|
|
|
131.5 |
|
|
|
3.0 |
|
|
|
3.0 |
|
Gynecology |
|
|
8 |
|
|
|
55.6 |
|
|
|
1.3 |
|
|
|
10 |
|
|
|
116.0 |
|
|
|
2.5 |
|
|
|
7 |
|
|
|
110.9 |
|
|
|
2.5 |
|
|
|
2.5 |
|
Others |
|
|
21 |
|
|
|
149.7 |
|
|
|
3.5 |
|
|
|
14 |
|
|
|
162.4 |
|
|
|
3.4 |
|
|
|
10 |
|
|
|
137.3 |
|
|
|
3.1 |
|
|
|
3.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
285 |
|
|
|
Rs.4303.2 |
|
|
|
100.0 |
% |
|
|
275 |
|
|
|
Rs.4,729.3 |
|
|
|
100.0 |
% |
|
|
234 |
|
|
|
Rs.4,360.2 |
|
|
|
U.S.$100.0 |
|
|
|
100.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
The categorization into therapeutic segments is based on current marketing practice and
focuses on therapies. |
|
(2) |
|
Refers to the therapeutic categorys revenues from sales in India expressed as a percentage
of our total revenues from sales in all of our therapeutic categories in India. |
|
(3) |
|
Products of the same strength sold in different packs have been re-grouped as one product in
fiscal 2005. |
The following tables summarize the position of our top 10 brands in the Indian market for
fiscal 2003, 2004 and 2005 respectively:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Therapeutic |
|
Therapeutic Sub- |
|
Fiscal Year Ended |
|
% |
Brand |
|
Category |
|
category |
|
March 31, 2005 |
|
Total(1)(3) |
|
|
|
|
|
|
(in millions) |
|
|
|
|
Nise |
|
Pain management |
|
Non-steroidal anti-inflammatory |
|
Rs. |
537.9 |
|
|
U.S.$ |
12.3 |
|
|
|
12.3 |
% |
Omez |
|
Gastro-intestinal |
|
Anti-ulcerant |
|
|
528.1 |
|
|
|
12.1 |
|
|
|
12.1 |
|
Stamlo |
|
Cardiovascular |
|
Anti-hypertensive |
|
|
298.2 |
|
|
|
6.8 |
|
|
|
6.8 |
|
Stamlo Beta |
|
Cardiovascular |
|
Anti-hypertensive |
|
|
186.7 |
|
|
|
4.3 |
|
|
|
4.3 |
|
Enam |
|
Cardiovascular |
|
Anti-hypertensive |
|
|
162.1 |
|
|
|
3.7 |
|
|
|
3.7 |
|
Atocor |
|
Cardiovascular |
|
Lipid lowering agent |
|
|
115.8 |
|
|
|
2.7 |
|
|
|
2.7 |
|
Clamp |
|
Anti-infectives |
|
Anti-infectives |
|
|
100.6 |
|
|
|
2.3 |
|
|
|
2.3 |
|
Mintop |
|
Dermatology |
|
Alopecia |
|
|
98.4 |
|
|
|
2.3 |
|
|
|
2.3 |
|
Ciprolet |
|
Anti-infectives |
|
Anti-bacterial |
|
|
96.3 |
|
|
|
2.2 |
|
|
|
2.2 |
|
Reclide |
|
Diabetes Management |
|
Sulphonylurea |
|
|
85.5 |
|
|
|
2.0 |
|
|
|
2.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
|
|
|
Rs. |
2,209.5 |
|
|
U.S.$ |
50.7 |
|
|
|
50.7 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Refers to the brands revenues from sales in India expressed as a percentage of our total
revenues from sales in all of our therapeutic categories in India. |
16
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rank of our Brand |
|
Market Share of |
|
|
|
|
|
Fiscal Year Ended March 31, |
|
|
Within Product |
|
Our Brand Within |
|
Brand |
|
|
|
|
Brand |
|
Category (1) |
|
Product Category (1) |
|
Growth %(2) |
|
2004 |
|
2003 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in millions) |
Nise |
|
|
1 |
|
|
|
23.2 |
% |
|
|
(4.3 |
%) |
|
|
Rs.655.6 |
|
|
|
Rs.654.5 |
|
Omez |
|
|
1 |
|
|
|
42.5 |
|
|
|
2.2 |
|
|
|
622.6 |
|
|
|
467.4 |
|
Stamlo |
|
|
1 |
|
|
|
24.0 |
|
|
|
6.5 |
|
|
|
293.2 |
|
|
|
253.8 |
|
Stamlo Beta |
|
|
2 |
|
|
|
15.2 |
|
|
|
3.1 |
|
|
|
187.7 |
|
|
|
154.2 |
|
Enam |
|
|
2 |
|
|
|
25.8 |
|
|
|
0.7 |
|
|
|
163.9 |
|
|
|
144.5 |
|
Atocor |
|
|
3 |
|
|
|
8.7 |
|
|
|
19.7 |
|
|
|
100.6 |
|
|
|
56.2 |
|
Clamp |
|
|
4 |
|
|
|
11.7 |
|
|
|
13.5 |
|
|
|
106.5 |
|
|
|
83.5 |
|
Mintop |
|
|
1 |
|
|
|
91.0 |
|
|
|
4.6 |
|
|
|
99.1 |
|
|
|
76.8 |
|
Ciprolet |
|
|
7 |
|
|
|
3.6 |
|
|
|
30.6 |
|
|
|
134.9 |
|
|
|
169.2 |
|
Reclide |
|
|
3 |
|
|
|
17.4 |
|
|
|
(5.5 |
) |
|
|
90.1 |
|
|
|
85.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rs.2,454.2 |
|
|
|
Rs.2,145.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Therapeutic sub-categories are the specific groups within each therapeutic category and
product categories are the compound groups within each therapeutic sub-category. Source: Operations
Research Group March 2005. |
|
(2) |
|
Revenue growth determined based on retail sales over the corresponding 12-month period for
the previous year. Source: Operations Research Group March 2005. |
Russia. Russia is our largest export market in this segment and our sales of
formulations in this market accounted for 26.9% of our revenues in the formulations segment in
fiscal 2005. Pharmexpert, a market research firm, ranked us number 16 in sales in Russia in fiscal
2005 in its December 2004 report. Pharmexpert also reported that our market share of sales in
Russia has increased from 1.26% in calendar 2003 to 1.31% in calendar 2004.
The following table provides a summary of our revenues in Russia by therapeutic category for
fiscal 2003, 2004 and 2005 respectively:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal Year Ended March 31, |
|
|
2003 |
|
2004 |
Therapeutic |
|
Number of |
|
|
|
|
|
% |
|
Number of |
|
|
|
|
|
% |
Category |
|
Products |
|
Revenues |
|
Total(1) |
|
Products |
|
Revenues |
|
Total(1) |
|
|
|
|
|
|
(in millions) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pain Management |
|
|
9 |
|
|
|
Rs.268.9 |
|
|
|
16.2 |
% |
|
|
9 |
|
|
|
Rs.477.4 |
|
|
|
26.8 |
% |
Anti-Infectives |
|
|
7 |
|
|
|
398.6 |
|
|
|
24.0 |
|
|
|
7 |
|
|
|
435.4 |
|
|
|
24.4 |
|
Gastro-Intestinal |
|
|
2 |
|
|
|
355.0 |
|
|
|
21.3 |
|
|
|
2 |
|
|
|
400.2 |
|
|
|
22.5 |
|
Cardiovascular |
|
|
4 |
|
|
|
331.7 |
|
|
|
20.0 |
|
|
|
4 |
|
|
|
338.2 |
|
|
|
19.0 |
|
Dermatology |
|
|
2 |
|
|
|
101.4 |
|
|
|
6.1 |
|
|
|
2 |
|
|
|
92.7 |
|
|
|
5.2 |
|
Others |
|
|
10 |
|
|
|
205.2 |
|
|
|
12.4 |
|
|
|
8 |
|
|
|
38.0 |
|
|
|
2.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
34 |
|
|
|
Rs.1,660.8 |
|
|
|
100.0 |
% |
|
|
32 |
|
|
|
Rs.1,781.8 |
|
|
|
100.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal Year Ended March 31, 2005 |
Therapeutic |
|
Number of |
|
|
|
|
|
|
|
|
|
% |
Category |
|
Products |
|
Revenues |
|
Total(1) |
|
|
|
|
|
|
(in millions) |
|
|
|
|
Pain Management |
|
|
9 |
|
|
|
Rs.660.3 |
|
|
U.S.$ |
15.1 |
|
|
|
31.3 |
% |
Anti-Infectives |
|
|
7 |
|
|
|
505.1 |
|
|
|
11.6 |
|
|
|
24.0 |
|
Gastro-Intestinal |
|
|
2 |
|
|
|
493.0 |
|
|
|
11.3 |
|
|
|
23.4 |
|
Cardiovascular |
|
|
4 |
|
|
|
306.2 |
|
|
|
7.0 |
|
|
|
14.5 |
|
Dermatology |
|
|
2 |
|
|
|
96.4 |
|
|
|
2.2 |
|
|
|
4.6 |
|
Others |
|
|
9 |
|
|
|
46.2 |
|
|
|
1.1 |
|
|
|
2.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
33 |
|
|
|
Rs.2,107.2 |
|
|
U.S.$ |
48.3 |
|
|
|
100.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Refers to the therapeutic categorys revenues from sales in Russia expressed as a
percentage of our total revenues from sales in all of our therapeutic categories in Russia. |
17
The following table provides a summary of our principal products in the Russian market
for fiscal 2003, 2004 and 2005 respectively:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal Year Ended March 31, |
|
|
|
|
|
|
2003 |
|
2004 |
|
2005 |
Brand |
|
Therapeutic Category |
|
Revenues |
|
%Total(1) |
|
Revenues |
|
%Total(1) |
|
Revenues |
|
%Total(1) |
|
|
|
|
|
|
(in millions) |
|
|
|
|
|
(in millions) |
|
|
|
|
|
(in millions) |
|
|
|
|
Omez |
|
Gastro-intestinal |
|
|
Rs.352.2 |
|
|
|
21.2 |
% |
|
|
Rs.394.6 |
|
|
|
22.1 |
% |
|
|
Rs.488.7 |
|
|
U.S.$ |
11.2 |
|
|
|
24.0 |
% |
Ciprolet |
|
Anti-infectives |
|
|
336.4 |
|
|
|
20.2 |
|
|
|
385.0 |
|
|
|
21.6 |
|
|
|
450.2 |
|
|
|
10.3 |
|
|
|
22.1 |
|
Ketorol |
|
Pain management |
|
|
166.4 |
|
|
|
10.0 |
|
|
|
263.1 |
|
|
|
14.8 |
|
|
|
339.3 |
|
|
|
7.8 |
|
|
|
16.7 |
|
Enam |
|
Cardiovascular |
|
|
354.2 |
|
|
|
21.3 |
|
|
|
338.2 |
|
|
|
19.0 |
|
|
|
306.2 |
|
|
|
7.0 |
|
|
|
15.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
|
|
|
|
Rs.1,209.2 |
|
|
|
72.7 |
% |
|
|
Rs.1,380.9 |
|
|
|
77.5 |
% |
|
|
Rs.1,584.5 |
|
|
U.S.$ |
36.3 |
|
|
|
75.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Refers to the brands revenues from sales in Russia expressed as a percentage of our total
revenues from all formulation sales in Russia. |
Our top four brands, Omez, Ciprolet, Ketorol and Enam, accounted for 75.2% of our
formulation revenues in Russia in fiscal 2005. Omez, our anti-ulcerant product and Ciprolet, our
product in the anti-infective segment, are ranked as the 26th and 42nd best selling formulation
brands, respectively, in the Russian market according to the Pharmexpert December 2004 report. Nise
has entered Pharmexperts top 100 rankings ranked at number 98 and has become the top selling non
steroidal anti-inflammatory drug on the Russian pharmaceutical market for the year ended December
2004, according to the Pharmexpert December 2004 report.
Growth during the year was driven by marketing initiatives such as targeting the hospital
segment, greater penetration in the key cities of Moscow and St. Petersburg and marketing campaigns
for key products
Our strategy in Russia is to focus on the therapeutic areas of gastro-intestinal, pain
management, anti-infectives and cardiovascular. Our focus is on building brand leaders in these
therapeutic segments. Omez, Ciprolet, Enam and Nise continued to be brand leaders in their
respective categories, as reported by the Pharmexpert December 2004 report.
Other Emerging Markets. We have operations in former Soviet Union countries other than Russia,
including Ukraine, Kazakhstan and Belarus. We also have operations in other emerging markets, such
as Venezuela, Vietnam, Sri Lanka, Romania and Myanmar. Our export of formulations to these
countries accounted for 12.6% of the revenues in our formulations segment in fiscal 2005.
We are also focusing on expanding our presence in China. In China, we market through our
equity investee, Kunshan Rotam Reddy Pharmaceuticals Co. Limited (KRRP). As of March 31, 2005, we
held a 51.2% equity interest in KRRP. We currently market eight products through KRRP in China and
have six products pending registration. During fiscal 2005, KRRP sold one product license and also
obtained approval for three new product licenses. The products made through these new product
licenses had not yet launched as of March 31, 2005.
Sales, marketing and distribution network
India. We generate demand for our products by promoting them to doctors who prescribe them,
and meeting with pharmacists to see that the pharmacists stock our brands. Our focus on brand
building is, therefore, primarily driven through efforts to build relationships with the medical
community. While we do not sell directly to doctors or pharmacists, our approximately 1,360 field
personnel frequently visit doctors and pharmacists throughout the country to promote our products.
In addition, we sponsor medical conferences in different parts of the country and conduct seminars
for doctors.
We sell our formulations primarily through clearing and forwarding agents to approximately
2,000 stockists who decide which brands to buy based on demand. The stockists pay for our products
pursuant to an agreed credit period and in turn sell these products to retailers. Our clearing and
forwarding agents are responsible for transporting our products to the stockists and ensuring that
the stockists maintain adequate supplies of our products. We pay our clearing and forwarding agents
on a commission basis. We have insurance policies that cover our products during shipment and
storage at clearing and forwarding locations.
Russia. In Russia, we sell directly to some of the principal national distributors. We also
distribute our products through our wholly owned subsidiary located in Russia, OOO Dr. Reddys
Laboratories Limited, Russia. Our sales and marketing efforts are driven by a team of 100
marketing representatives, 11 regional managers, 4 zone managers and 8 key account managers to
promote our products to doctors in 48 cities in Russia.
18
In the Russian market, credit is generally extended only to customers after they have
established a satisfactory history of payment with us. The credit ratings of these customers are
based on turnover, payment record and the number of the customers branches or pharmacies and are
reviewed on a periodic basis.
Other Emerging Markets. In other emerging markets, our key focus markets are China,
Kazakhstan, Uzbekistan, Ukraine Belarus, Vietnam, Romania and Sri Lanka where we have our own sales
personnel to promote our products. In China, where we market through KRRP, we have 94 marketing
representatives covering hospitals. In several of these emerging markets, we market and distribute
through local agents. We also have representative offices in several of these countries.
Manufacturing
We have four facilities for the manufacture of formulation products, all of which are situated
in India. We also use third-party manufacturing facilities. The main difference between active
pharmaceutical ingredients as compared to formulations and generics is the form in which they are
produced and the way they are packaged. Active pharmaceutical ingredients are manufactured and
distributed in bulk. In formulations and generics, these bulk ingredients are converted into
finished dosages by adding other ingredients, called excipients, and packaged into individual doses
that are ready for consumption by the patient. In fiscal 2005, our active pharmaceutical
ingredients operations provided 48.0% of the active pharmaceutical ingredients and intermediates
requirements of our formulations business, with the balance coming from various other suppliers.
Our manufacture of formulations is subject to strict quality and contamination controls
throughout the manufacturing process. Each production line consists of a series of rooms through
which the product passes at different stages of its conversion to a finished dosage. In our
facilities, we manufacture formulations in various dosage forms including tablets, capsules,
injections and liquids. These dosage forms are then packaged and quarantined to be tested for
quality and contamination. The Ministries of Health of Sudan, Brazil, Latvia and Romania have
inspected some of our manufacturing plants. One of our facilities also has the approval of the U.K.
Medicines and Health Care Products Regulatory Agency (MHRA). During fiscal 2005, we initiated
the construction of a new facility at Baddi in the state of Himachal Pradesh, India to take
advantage of certain financial benefits, which include exemption from income tax and excise duty
for a specified period, offered by the government of India to encourage industrial growth in the
state of Himachal Pradesh.
Competition
We compete with different companies in different countries, depending upon therapeutic and
product categories, and within each category upon dosage strengths and drug delivery. On the basis
of sales, we are the seventh largest pharmaceutical seller in India, with a market share of 2.4%
according to the ORG IMS March Moving Annual Total report for the 12 month period ending March
2005. Of the top ten participants in the Indian formulations market, three are multinational
corporations and the rest are Indian corporations.
The business opportunities in India are on the rise and the Indian pharmaceutical business
environment underwent considerable changes in fiscal 2005. Some of the most significant changes in
the industry are as follows:
|
§ |
|
Introduction of the product patent regime, effective as of January 1, 2005; |
|
|
§ |
|
Implementation of the Value Added Tax (VAT) system, effective as of April 1, 2005; |
|
|
§ |
|
Introduction of the Maximum Retail Price (MRP)-based excise duty structure for the
pharmaceutical industry; |
|
|
§ |
|
Higher investments by Indian companies in research and development, as well as an
increase in the number of new product launches by Indian companies; and |
|
|
§ |
|
Improvement in sales of multinational corporations and increasing interest of global
multinationals in India. |
Our formulation segments principal competitors in the Indian market are Cipla Limited, Glaxo
SmithKline Pharmaceuticals Limited, Ranbaxy Laboratories Limited, Nicholas Piramal India Limited,
Sun Pharmaceuticals Industries Limited and Zydus-Cadila.
In our export markets, we compete with local companies, multinational corporations and players
from other emerging markets. In Russia and in most of our export markets, we believe our products
occupy a niche position between the less expensive local products and the more expensive products
of the multinational corporations.
19
Government regulations
All pharmaceutical companies that manufacture and market products in India are subject to
various national and state laws and regulations, which principally include the Drugs and Cosmetics
Act, 1940, the Drugs (Prices Control) Order, 1995 (DPCO), various environmental laws, labor laws
and other government statutes and regulations. These regulations govern the testing, manufacturing,
packaging, labeling, storing, record keeping, safety, approval, advertising, promotion, sale and
distribution of pharmaceutical products.
In India, manufacturing licenses for drugs and pharmaceuticals are generally issued by state
drug authorities. Under the Drugs and Cosmetics Act, 1940, the state drug administrations are
empowered to issue manufacturing licenses for drugs if they are approved for marketing in India by
the Drug Controller General of India (DCGI). Prior to granting licenses for any new drugs or
combinations of new drugs, DCGI clearance has to be obtained in accordance with the Drugs and
Cosmetics Act, 1940.
Pursuant to the amendments in May 2005 to the Schedule Y of the Drugs and Cosmetics Act, 1940,
manufacturers of finished dosages are required to submit additional technical data to the DCGI in
order to obtain a no-objection certificate for conducting clinical trials as well as to manufacture
new drugs for marketing.
All pharmaceutical manufacturers that sell products in any country are subject to regulations
issued by the ministry of health (MoH) of the respective country. These regulations govern or
influence the testing, manufacturing, packaging, labeling, storing, record-keeping, safety,
approval, advertising, promotion, sale and distribution of products.
Our facilities and products are periodically inspected by various regulatory authorities such
as the U.K. MHRA, the South African Medicines Control Council, the Brazilian National Agency of
Sanitary Surveillance (also known as ANVISA), the Romanian National Medicines Agency, and the
World Health Organization, all of which have extensive enforcement powers over the activities of
pharmaceutical manufacturers operating within their jurisdiction.
MoH approval of an application is required before a generic equivalent of an existing or
referenced brand drug can be marketed. When processing a generics application, the MoH waives the
requirement of conducting complete clinical studies, although it normally requires bioavailability
and/or bioequivalence studies. Bioavailability indicates the rate and extent of absorption and
levels of concentration of a drug product in the blood stream needed to produce a therapeutic
effect. Bioequivalence compares the bioavailability of one drug product with another, and when
established, indicates that the rate of absorption and levels of concentration of the active drug
substance in the body are the equivalent for the generic drug and the previously approved drug. A
generic application may be submitted for a drug on the basis that it is the equivalent of a
previously approved drug. Before approving a generic product, the MoH also requires that our
procedures and operations conform to Current Good Manufacturing Practice (cGMP) regulations,
relating to good manufacturing practices as defined by various countries. We must follow the cGMP
regulations at all times during the manufacture of our products. We continue to spend significant
time, money and effort in the areas of production and quality testing to help ensure full
compliance with cGMP regulations.
The timing of final MoH approval of a generic application depends on various factors,
including patent expiration dates, sufficiency of data and regulatory approvals.
The government of India established the National Pharmaceutical Pricing Authority (NPPA) to
control pharmaceutical prices. Under the DPCO, the NPPA has the authority to designate a
pharmaceutical product as a specified product and fix the maximum selling price for such product.
At present, 74 drugs and their formulations are categorized as specified products by NPPA. A
limited number of our formulation products fall in this category.
On
March 22, 2005, the government of India passed the Patents
(Amendment) Bill 2005 (the Amendment), introducing a
product patent regime for food, chemicals and pharmaceuticals in
India. The Amendment specifically provides that new medicines
(patentability of which is not specifically excluded) for which a
patent has been applied for in India on or after January 1, 1995
and for which a patent is granted cannot be manufactured or sold in
India by other than the patent holder and its assignees and
licensees. This will result in a reduction of the new product
introductions in India, as well as other countries where a similar
legislation has been introduced, for all Indian pharmaceutical
companies engaged in the development and marketing of generic
finished dosages and APIs. Processes for the manufacture of APIs and
formulations were patentable in India even prior to the Amendment, so
no additional impact is anticipated from patenting of such processes.
20
Active Pharmaceutical Ingredients and Intermediates (API) Segment
Our active pharmaceutical ingredients and intermediates business contributed 35.7% of our
total revenues for fiscal 2005. Active pharmaceutical ingredients are the principal ingredients for
finished dosages and are also known as bulk actives or bulk drugs. Active pharmaceutical
ingredients become formulations when the dosage is prepared for human consumption in the form of a
tablet, capsule or liquid using additional inactive ingredients. Intermediates are the compounds
from which active pharmaceutical ingredients are prepared. We produce and market more than 100
different active pharmaceutical ingredients and intermediates in several markets. We export active
pharmaceutical ingredients to emerging as well as developed markets covering over 70 countries. Our
principal markets in this business segment include North America and Europe, which together
contributed 42.3% of the segments revenues. Our active pharmaceutical ingredients business is run
independently from our formulations and generics businesses and, in addition to supplying API to
the formulations and generics businesses, we sell products to third parties for use in creating
generic products. Our active pharmaceutical ingredients business also supports our custom
pharmaceutical services business by way of manufacture of required API. The research and
development group within the active pharmaceutical ingredients and intermediates division
contributes to our business by creating intellectual property (principally with respect to novel
and non-infringing manufacturing processes and intermediates), providing research intended to
reduce the cost of production of our products and developing approximately 15-20 new products every
year.
The following table sets forth active pharmaceutical ingredients and intermediates revenues by
geographic area for fiscal 2003, 2004 and 2005 respectively:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal Year Ended March 31, |
|
|
2003 |
|
2004 |
|
2005 |
|
|
Revenues |
|
% Total (1) |
|
Revenues |
|
% Total(1) |
|
Revenues |
|
% Total(1) |
|
|
(in millions) |
|
|
|
|
|
(in millions) |
|
|
|
|
|
(in millions) |
|
|
|
|
Emerging markets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
India |
|
Rs. |
1,749.1 |
|
|
|
27.6 |
% |
|
Rs. |
2,115.1 |
|
|
|
27.7 |
% |
|
Rs. |
1,972.1 |
|
|
|
U.S.$45.2 |
|
|
|
28.4 |
% |
Bangladesh |
|
|
88.6 |
|
|
|
1.4 |
|
|
|
94.1 |
|
|
|
1.2 |
|
|
|
127.4 |
|
|
|
2.9 |
|
|
|
1.8 |
|
Other countries |
|
|
1,582.6 |
|
|
|
24.9 |
|
|
|
1,847.5 |
|
|
|
24.3 |
|
|
|
1,841.8 |
|
|
|
42.2 |
|
|
|
26.5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total emerging markets |
|
|
3,420.3 |
|
|
|
53.9 |
|
|
|
4,056.7 |
|
|
|
53.2 |
|
|
|
3,941.3 |
|
|
|
90.4 |
|
|
|
56.8 |
|
|
Developed markets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
North America |
|
|
2,397.7 |
|
|
|
37.8 |
|
|
|
1,902.9 |
|
|
|
24.9 |
% |
|
|
1,849.0 |
|
|
|
42.4 |
|
|
|
26.6 |
|
Europe |
|
|
465.9 |
|
|
|
7.4 |
|
|
|
1,626.9 |
|
|
|
21.3 |
|
|
|
1,091.1 |
|
|
|
25.0 |
|
|
|
15.7 |
|
Japan |
|
|
56.8 |
|
|
|
0.9 |
|
|
|
42.0 |
|
|
|
0.6 |
|
|
|
63.1 |
|
|
|
1.4 |
|
|
|
0.9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total developed markets |
|
|
2,920.4 |
|
|
|
46.1 |
|
|
|
3,571.8 |
|
|
|
46.8 |
|
|
|
3,003.2 |
|
|
|
68.8 |
|
|
|
43.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
Rs. |
6,340.7 |
|
|
|
100.0 |
% |
|
Rs. |
7,628.5 |
|
|
|
100.0 |
% |
|
Rs. |
6,944.5 |
|
|
|
U.S.$159.2 |
|
|
|
100.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Refers to our revenues from API sales in the applicable country expressed as a percentage of
our total revenues from API sales throughout the world. |
21
The following table sets forth the sales of our key active pharmaceutical ingredients and
intermediates for fiscal 2003, 2004 and 2005 respectively:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal Year Ended March 31, |
|
|
|
|
|
|
2003 |
|
2004 |
|
2005 |
|
|
Therapeutic |
|
Therapeutic |
|
|
|
|
|
|
|
|
|
|
|
|
Product |
|
Category |
|
Sub-category |
|
Revenues |
|
%Total (1) |
|
Revenues |
|
%Total(1) |
|
Revenues |
|
%Total(1) |
|
|
|
|
|
|
(in millions) |
|
(in millions) |
|
|
|
|
|
(in millions) |
|
|
|
|
|
|
|
|
Ramipril |
|
Cardiovascular |
|
Anti-hypertensive |
|
|
Rs.53.1 |
|
|
|
0.80 |
% |
|
Rs. |
1,314.2 |
|
|
|
17.20 |
% |
|
Rs. |
783.4 |
|
|
U.S.$ |
18.0 |
|
|
|
11.3 |
% |
Ranitidine HCL |
|
Gastro-intestinal |
|
Anti-ulcerant |
|
|
697.3 |
|
|
|
11.0 |
|
|
|
711.4 |
|
|
|
9.3 |
|
|
|
734.3 |
|
|
|
16.8 |
|
|
|
10.6 |
|
Ciprofloxacin HCL |
|
Anti-infective |
|
Anti-bacterial |
|
|
773.2 |
|
|
|
12.2 |
|
|
|
959.8 |
|
|
|
12.6 |
|
|
|
619.1 |
|
|
|
14.2 |
|
|
|
8.9 |
|
Naproxen sodium |
|
Pain management |
|
Anti-inflammatory |
|
|
400.8 |
|
|
|
6.3 |
|
|
|
437.3 |
|
|
|
5.7 |
|
|
|
470.0 |
|
|
|
10.8 |
|
|
|
6.8 |
|
Ibuprofen |
|
Pain management |
|
Analgesic |
|
|
455.8 |
|
|
|
7.2 |
|
|
|
394.6 |
|
|
|
5.2 |
|
|
|
460.5 |
|
|
|
10.6 |
|
|
|
6.6 |
|
Atorvastatin |
|
Cardiovascular |
|
Lipid-lowering agent |
|
|
88.3 |
|
|
|
1.4 |
|
|
|
211.2 |
|
|
|
2.8 |
|
|
|
252.5 |
|
|
|
5.8 |
|
|
|
3.6 |
|
Naproxen |
|
Pain management |
|
Anti-inflammatory |
|
|
160.1 |
|
|
|
2.5 |
|
|
|
233.8 |
|
|
|
3.1 |
|
|
|
229.6 |
|
|
|
5.3 |
|
|
|
3.3 |
|
Nizatidine |
|
Gastro-intestinal |
|
Anti-ulcerant |
|
|
658.7 |
|
|
|
10.4 |
|
|
|
159.6 |
|
|
|
2.1 |
|
|
|
216.8 |
|
|
|
5.0 |
|
|
|
3.1 |
|
Terbinafine HCL |
|
Anti-infective |
|
Anti-fungal |
|
|
94.0 |
|
|
|
1.5 |
|
|
|
124.9 |
|
|
|
1.6 |
|
|
|
194.5 |
|
|
|
4.5 |
|
|
|
2.8 |
|
Losartan potassium |
|
Cardiovascular |
|
Anti-hypertensive |
|
|
125.5 |
|
|
|
2.0 |
|
|
|
214.2 |
|
|
|
2.8 |
|
|
|
180.5 |
|
|
|
4.1 |
|
|
|
2.6 |
|
Dextromethorphan |
|
Respiratory |
|
Anti-allergic |
|
|
190.4 |
|
|
|
3.0 |
|
|
|
182.8 |
|
|
|
2.4 |
|
|
|
165.8 |
|
|
|
3.8 |
|
|
|
2.4 |
|
Sertraline HCL |
|
Cardiovascular |
|
Anti-hypertensive |
|
|
143.1 |
|
|
|
2.3 |
|
|
|
178.4 |
|
|
|
2.3 |
|
|
|
138.2 |
|
|
|
3.2 |
|
|
|
2.0 |
|
Sparfloxacin |
|
Anti-infective |
|
Anti-bacterial |
|
|
175.8 |
|
|
|
2.8 |
|
|
|
197.1 |
|
|
|
2.6 |
|
|
|
117.5 |
|
|
|
2.7 |
|
|
|
1.7 |
|
Doxazosin mesylate |
|
Cardiovascular |
|
Anti-hypertensive |
|
|
181.4 |
|
|
|
2.9 |
|
|
|
117.9 |
|
|
|
1.5 |
|
|
|
111.6 |
|
|
|
2.6 |
|
|
|
1.6 |
|
Amlodipine maleate |
|
Cardiovascular |
|
Calcium channel blockers |
|
|
12.4 |
|
|
|
0.2 |
|
|
|
13.4 |
|
|
|
0.2 |
|
|
|
105.4 |
|
|
|
2.4 |
|
|
|
1.5 |
|
|
|
|
(1) |
|
Refers to our revenues from key API sales expressed as a percentage of our total API
revenues. |
Sales, Marketing and Distribution
Emerging Markets. India is the single largest market in this region, contributing 28.4% to
the segments revenues in fiscal 2005. In India, we market our active pharmaceutical ingredients to
Indian and multinational companies who are also our competitors in the formulations segment.
In India, our top six products are ciprofloxacin, ranitidine, losartan potassium, ibuprofen,
atorvastatin and sparfloxacin. The market in India is highly competitive with severe pricing
pressure and competition from cheaper Chinese imports in several products.
In India, our sales team works closely with our sales agents to market our products. We market
our products through these sales agents, commonly referred to as indenting agents, with a focus
on regional sales and marketing. The sales are made directly from the factory and to a limited
extent through clearing and forwarding agents. Distribution through clearing and forwarding agents
is done to give better service to the customer.
Our sales to other emerging markets were at Rs.1,941.6 million for fiscal 2005. Our key
emerging markets include South Korea, China, Taiwan, Argentina, Brazil, Mexico, Turkey, Egypt,
Saudi Arabia, South Africa and Kenya. While we work through our agents in these markets, our zonal
marketing managers also interact directly with our key customers in order to service their
requirements. Our strategy is to build relationships with top customers in each of these markets
and partner with them in product launches by providing timely technical and analytical support.
Developed Markets. Our principal markets are North America and Europe. In the United States
and Europe, over the next five years, a large number of products are expected to lose patent
protection, providing growth opportunities for our active pharmaceutical ingredients business. We
have been marketing APIs in the United States for over a decade. We market through our subsidiaries
in the United States and Europe. These subsidiaries are engaged in all aspects of marketing
activity and support our customers pursuit of regulatory approval for their products.
As of June 30, 2005, we had 77 DMFs on file in the United States. As of June 30, 2005, we had
filed 39 DMFs in Europe and had 14 certificates of suitability granted by European authorities. For
most of these, we are either already supplying commercial quantities or development quantities to
various generic formulators.
Manufacturing and Raw Materials
22
We have seven facilities for the manufacture of our APIs. These facilities have been inspected
by the U.S. FDA and follow cGMP. All of these facilities are situated in the state of Andhra
Pradesh, India. Each of these facilities has ISO 9000 certification. With over 500 reactors of
different sizes offering 1.8 million litres of reaction volume annually, we have the flexibility to
produce quantities that range from a few kilograms to several metric tons. The manufacturing
process consumes a wide variety of raw materials that we obtain from sources that comply with the
requirements of regulatory authorities in the markets to which we supply our products. We procure
raw materials on the basis of our requirement planning cycles. We utilize a broad base of suppliers
in order to minimize risk arising from dependence on a single supplier. Where possible, we have
also entered into annual quantity and price contracts to reduce possible supply risks and minimize
costs. Our formulations and generics businesses source approximately 48.0% and 69.6% respectively,
of their API purchases from our API segment. We also outsource the manufacturing of some of our
APIs to third-party manufacturers. The API segment also sources several APIs from third party
suppliers for the emerging markets to optimally utilize the in-house manufacturing capacities for
the developed markets, which are more profitable relative to the emerging markets. During fiscal
2005, 11.3% of our total revenues resulted from sale of APIs procured from third-party suppliers.
We maintain stringent quality controls when procuring materials from third-party suppliers.
Competition
The global API market can broadly be divided into regulated and less regulated markets. The
less regulated markets offer low entry barriers in terms of regulatory requirements with respect to
the qualification process and intellectual property rights. The regulated markets, like the United
States and Europe, have high regulatory entry barriers in terms of cGMP and approved facilities. As
a result, there is a premium for quality and regulatory compliance along with relatively greater
stability for both volumes and prices.
During fiscal 2005, the competitive environment for the API industry underwent significant
changes. These changes included increased competition from companies based in India and China and
increasing trends of consolidation in the global generic industry, with some of the key generics
companies beginning to strengthen their in-house API development capabilities.
We compete with a number of manufacturers within and outside India, which vary in size. Our
main competitors in this segment are Hetero Drugs Limited, Divis Laboratories Limited, Shasun
Chemicals and Drugs Limited, Aurobindo Pharma Limited, Ranbaxy Laboratories Limited, Cipla Limited,
Matrix Laboratories Limited and Biocon India Limited, all based in India. In addition, we
experience competition from European and Chinese manufacturers, as well as from Teva
Pharmaceuticals Industries Limited, based in Israel.
Government regulations
All pharmaceutical companies that manufacture and market products in India are subject to
various national and state laws and regulations, which principally include the Drugs and Cosmetics
Act, 1940, the Drugs (Prices Control) Order, 1995, various environmental laws, labor laws and other
government statutes and regulations. These regulations govern the testing, manufacturing,
packaging, labeling, storing, record keeping, safety, approval, advertising, promotion, sale and
distribution of pharmaceutical products.
In India, manufacturing licenses for drugs and pharmaceuticals are generally issued by state
drug authorities. Under the Drugs and Cosmetics Act, 1940, the state drug administrations are
empowered to issue manufacturing licenses for drugs if they are approved for marketing in India by
the DCGI. Prior to granting licenses for any new drugs or combinations of new drugs, the DCGI
clearance has to be obtained in accordance with the Drugs and Cosmetics Act, 1940.
The government of India established the National Pharmaceutical Pricing Authority (NPPA) to
control pharmaceutical prices. Under the DPCO, the NPPA has the authority to designate a
pharmaceutical product as a specified product and fix the maximum selling price for such product.
At present, 74 drugs and their formulations are categorized as specified products by NPPA. A
limited number of our API products fall in this category.
On
March 22, 2005, the government of India passed the Patents
(Amendment) Bill 2005 (the Amendment), introducing a
product patent regime for food, chemicals and pharmaceuticals in
India. The Amendment specifically provides that new medicines
(patentability of which is not specifically excluded) for which a
patent has been applied for in India on or after January 1, 1995
and for which a patent is granted cannot be manufactured or sold in
India by other than the patent holder and its assignees and
licensees. This will result in a reduction of the new product
introductions in India, as well as other countries where a similar
legislation has been introduced, for all Indian pharmaceutical
companies engaged in the development and marketing of generic
finished dosages and APIs. Processes for the manufacture of APIs and
formulations were patentable in India even prior to the Amendment, so
no additional impact is anticipated from patenting of such processes.
23
We submit a DMF for active pharmaceutical ingredients to be commercialized in the United
States. Any drug product for which an Abbreviated New Drug Application (ANDA) is being filed
must have a DMF in place with respect to a particular supplier supplying the underlying active
pharmaceutical ingredient. The manufacturing facilities are inspected by the U.S. FDA to assess
cGMP compliance. The manufacturing facilities and production procedures utilized at the
manufacturing facilities must meet U.S. FDA standards before products may be exported to the United
States. Six of our manufacturing facilities have been inspected by the U.S. FDA and found
Acceptable. For European markets, we submit a European DMF and, where applicable, obtain a
certificate of suitability from the European Directorate for the Quality of Medicines.
Generics Segment
Generic drugs are the chemical and therapeutic equivalents of reference brand drugs, typically
sold under their generic chemical names at prices below those of their brand drug equivalents.
These drugs are required to meet governmental standards that are similar to those applicable to
their brand-name equivalents and must receive regulatory approval prior to their sale in any given
country.
Our generics operations started in the second half of fiscal 2001. Our generic products are
marketed principally in North America and Europe.
This segment accounted for 18.4% of our total revenues for fiscal 2005, contributing
Rs.3,577.4 million. Revenues from sales of fluoxetine capsules in North America accounted for 26.0%
of our total revenues in this segment in fiscal 2005. Significant product launches in fiscal 2005
included citalopram HBr tablets and ciprofloxacin tablets in the U.S. and pravastatin tablets in
the U.K.
In fiscal 2005, revenues from this segment from sales in Europe were Rs.1,339.6 million,
Rs.2,230.1 million from sales in North America and Rs.7.7 million from sales in the rest of the
world.
The following table sets forth the sales of our principal generics finished dosages for fiscal
2003, 2004 and 2005 respectively:
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|
|
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|
|
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|
Fiscal Year Ended March 31, |
|
|
|
|
|
|
2003 |
|
2004 |
|
2005 |
|
|
|
|
|
|
Revenues |
|
|
|
|
|
Revenues |
|
|
|
|
|
Revenues |
|
Revenues |
|
|
|
|
|
|
Therapeutic |
|
(in |
|
% |
|
(in |
|
% |
|
(in |
|
(in |
|
% |
Region / Product |
|
Therapeutic Category |
|
Sub-Category |
|
millions) |
|
Total(1) |
|
millions) |
|
Total(1) |
|
millions) |
|
million) |
|
Total(1) |
North America |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fluoxetine capsules |
|
Central nervous system |
|
Anti-psychotic |
|
Rs. |
2,007.4 |
|
|
|
46.9 |
% |
|
Rs. |
1,898.4 |
|
|
|
43.8 |
% |
|
Rs. |
928.5 |
|
|
U.S.$ |
21.3 |
|
|
|
26.0 |
% |
Tizanidine tablets |
|
Spasticity |
|
Muscle relaxant |
|
|
777.8 |
|
|
|
18.2 |
% |
|
|
591.1 |
|
|
|
13.6 |
% |
|
|
206.2 |
|
|
|
4.7 |
|
|
|
5.8 |
% |
Citalopram tablets |
|
Central nervous system |
|
Anti-psychotic |
|
|
|
|
|
|
0.0 |
% |
|
|
|
|
|
|
0.0 |
% |
|
|
201.6 |
|
|
|
4.6 |
|
|
|
5.6 |
% |
Ibuprofen tablets |
|
Pain management |
|
Analgesic |
|
|
31.6 |
|
|
|
0.7 |
% |
|
|
184.0 |
|
|
|
4.2 |
% |
|
|
198.7 |
|
|
|
4.6 |
|
|
|
5.6 |
% |
Ranitidine tablets |
|
Gastro-intestinal |
|
Anti-ulcerant |
|
|
225.1 |
|
|
|
5.3 |
% |
|
|
205.8 |
|
|
|
4.7 |
% |
|
|
194.0 |
|
|
|
4.4 |
|
|
|
5.4 |
% |
Ciproflaxacin
tablets |
|
Anti-infective |
|
Anti-bacterial |
|
|
|
|
|
|
0.0 |
% |
|
|
1.6 |
|
|
|
0.0 |
% |
|
|
166.1 |
|
|
|
3.8 |
|
|
|
4.6 |
% |
Famotidine tablets |
|
Gastro-intestinal |
|
Anti-ulcerant |
|
|
170.4 |
|
|
|
4.0 |
% |
|
|
143.4 |
|
|
|
3.3 |
% |
|
|
141.1 |
|
|
|
3.2 |
|
|
|
3.9 |
% |
Ranitidine capsules |
|
Gastro-intestinal |
|
Anti-ulcerant |
|
|
196.5 |
|
|
|
4.6 |
% |
|
|
167.3 |
|
|
|
3.9 |
% |
|
|
84.9 |
|
|
|
1.9 |
|
|
|
2.4 |
% |
|
|
|
|
|
|
|
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|
|
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|
|
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|
|
|
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Europe |
|
|
|
|
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|
|
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|
|
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|
|
|
|
|
|
Omeprazole capsules |
|
Gastro-intestinal |
|
Anti-ulcerant |
|
|
283.0 |
|
|
|
6.6 |
% |
|
|
325.3 |
|
|
|
7.5 |
% |
|
|
434.1 |
|
|
|
10.0 |
|
|
|
12.1 |
% |
Amlodipine maleate
tablets |
|
Cardiovascular |
|
Anti-hypertensive |
|
|
|
|
|
|
0.0 |
% |
|
|
17.7 |
|
|
|
0.4 |
% |
|
|
219.9 |
|
|
|
5.0 |
|
|
|
6.1 |
% |
|
|
|
(1) |
|
Refers to our revenues from generics sales in the applicable region expressed as a
percentage of our total revenues from generics sales throughout the world. |
Generic drugs may be manufactured and marketed only if relevant patents on their brand
name equivalents and any additional government-mandated market exclusivity periods have expired,
been challenged and invalidated, or otherwise validly circumvented.
24
Generic pharmaceutical sales have increased significantly in recent years, due in part to an
increased awareness and acceptance among consumers, physicians and pharmacists that generic drugs
are the equivalent of brand-name drugs. Among the factors contributing to this increased awareness
are the passage of legislation permitting or encouraging substitution and the publication by
regulatory authorities of lists of equivalent drugs, which provide physicians and pharmacists with
generic drug alternatives. In addition, various government agencies and many private managed care
or insurance programs encourage the substitution of generic drugs for brand-name pharmaceuticals as
a cost-savings measure in the purchase of, or reimbursement for, prescription drugs. We believe
that these factors, together with the large volume of branded products losing patent protection
over the coming years, should lead to continued expansion of the generic pharmaceuticals market as
a whole. We intend to capitalize on the opportunities resulting from this expansion of the market
by leveraging our product development capabilities, manufacturing capacities inspected by various
international regulatory agencies and access to our own APIs, which offer significant supply chain
efficiencies.
Through the coordinated efforts of our teams in the U.S., Europe and India, we constantly seek
to expand our pipeline of generic products. As of March 31, 2005, our U.S. generic pipeline
comprised 45 ANDAs pending approval. Of these ANDAs, 29 were submitted as Paragraph IV filings
under the Hatch-Waxman Act. As of March 31, 2005, we had received final approval for 15 ANDAs.
Between March 31, 2005 and June 30, 2005, we filed 2 additional ANDAs with the U.S.FDA.
In the European Union, during fiscal 2005 we submitted product license applications for 6
generic drugs to the U.K. Medicines and Healthcare products Regulatory Agency (MHRA). In
addition, we have also completed Mutual Recognition Procedures for one generic drug in several
countries in Europe. Between March 31, 2005 and June 30, 2005, we submitted additional product
license applications for 2 products to the MHRA.
In South Africa, we have filed five product dossiers with the Medicine Control Council
(MCC), of which four have been approved and one is under review.
In Canada, we have filed three product dossiers with the Therapeutic Product Programme
(TPP), of which two have been approved and the remaining one is under review.
25
The following is a table containing applications filed with and approved by the appropriate
regulatory authorities as of March 31, 2005:
|
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|
|
|
|
|
|
|
|
Therapeutic |
|
|
Product (1) |
|
Therapeutic Category |
|
Sub-Category |
|
Patent Expiry |
United States |
|
|
|
|
|
|
Ranitidine (75 mg t,150/300 mg c) |
|
Gastro-intestinal |
|
Anti-ulcerant |
|
Expired |
Famotidine (10 mg t, 20/40 mg t) |
|
Gastro-intestinal |
|
Anti-ulcerant |
|
Expired |
Fluoxetine (10 mg t, 10/20/40 mg c) |
|
Central nervous system |
|
Anti-psychotic |
|
Expired |
Oxaprozin (600 mg t) |
|
Pain management |
|
Anti-inflammatory |
|
Expired |
Enalapril maleate & hydrochlortiazide (5-12.5 /10-25 mg t) |
|
Cardiovascular |
|
Anti-hypertensive |
|
Expired |
Ibuprofen (200/400/600/800 mg t) |
|
Pain management |
|
Analgesic |
|
Expired |
Tizanidine (2 / 4 mg t) |
|
Spasticity |
|
Muscle relaxant |
|
Expired |
Nefazodone HCl (50/100/150/200/250 mg t) |
|
Central nervous system |
|
Anti-psychotic |
|
Expired |
Ciprofloxacin (100/250/500/750 mg t) |
|
Anti-infective |
|
Anti-bacterial |
|
Expired |
Citalopram HBr (10/20/40 mg t) |
|
Central nervous system |
|
Anti-psychotic |
|
Expired |
Fluconazole (50/100/150/200 mg t) |
|
Anti-infective |
|
Anti-fungal |
|
Expired |
|
|
|
|
|
|
|
Europe(2) |
|
|
|
|
|
|
Ranitidine (150/300 mg t) |
|
Gastro-intestinal |
|
Anti-ulcerant |
|
Expired |
Ciprofloxacin (100/250/500/750 mg t) |
|
Anti-infective |
|
Anti-bacterial |
|
Expired |
Omeprazole (10/20/40 mg c) |
|
Gastro-intestinal |
|
Anti-ulcerant |
|
Expired |
Nizatidine (150 /300 mg c) |
|
Gastro-intestinal |
|
Anti-ulcerant |
|
Expired |
Amlodipine maleate (5/10 mg t) |
|
Cardiovascular |
|
Anti-hypertensive |
|
Expired |
Fluoxetine (20 mg c) |
|
Central nervous system |
|
Anti-psychotic |
|
Expired |
Terbinafine (125/250 mg t) |
|
Anti-infective |
|
Anti-fungal |
|
August 2005 |
|
|
|
|
|
|
|
South Africa |
|
|
|
|
|
|
Omeprazole (10/20/40 mg c) |
|
Gastro-intestinal |
|
Anti-ulcerant |
|
Expired |
Ranitidine (75 mg t) |
|
Gastro-intestinal |
|
Anti-ulcerant |
|
Expired |
Enalapril maleate (2.5/5/10/20 mg t) |
|
Cardiovascular |
|
Anti-hypertensive |
|
Expired |
Ciprofloxacin (100/250/500/750 mg t) |
|
Anti-infective |
|
Anti-bacterial |
|
Expired |
|
|
|
|
|
|
|
Canada |
|
|
|
|
|
|
Fluoxetine (10/20/40 mg c) |
|
Central nervous system |
|
Anti-psychotic |
|
Expired |
Ciprofloxacin (100/250/500/750 mg t) |
|
Anti-infective |
|
Anti-bacterial |
|
Expired |
|
|
|
|
|
|
|
Australia |
|
|
|
|
|
|
Norfloxacin (400mg t) |
|
Anti-infective |
|
Anti-bacterial |
|
Expired |
|
|
|
|
|
|
|
New Zealand |
|
|
|
|
|
|
Norfloxacin (400mg t) |
|
Anti-infective |
|
Anti-bacterial |
|
Expired |
|
|
|
(1) |
|
c = capsule, t = tablet |
|
(2) |
|
Applications were filed in one or more of the United Kingdom, Germany or France. Once
approval for a generic drug is obtained in one of these countries, approvals can be obtained in
other European Union countries upon expiration of the patent in that other country. |
Sales, Marketing and Distribution Network
North America. Dr. Reddys Laboratories, Inc., our wholly-owned subsidiary in the U.S., is
engaged in the marketing of our generic products in North America. In early 2003, we commenced
sales of generic products under our own label. We have our own sales and marketing team to market
these generic products. During fiscal 2005, we launched naproxen tablets, citalopram Hbr tablets,
ciprofloxacin tablets and fluconazole tablets under our label. Key account representatives for
generic products call on purchasing agents for chain drug stores, drug wholesalers, health
maintenance organizations and pharmacy buying groups. They also contact retail pharmacy chains and
support the retailers selling efforts with exhibits at key medical and pharmaceutical conventions.
Strategic Alliances. In 2001, we entered into a profit sharing marketing alliance with Par
Pharmaceuticals, Inc. to market certain prescription generic formulations, none of which are
over-the-counter products. We currently market 6 generic products through Par Pharmaceuticals, Inc.
We market famotidine tablets 10 mg and ranitidine tablets 75 mg through Leiner Health Products,
LLC (Leiner). In 2002, we entered into a 15-year exclusive agreement with Leiner to
26
market additional over-the-counter products in the United States. We have not launched any
product under this agreement. In Canada, we entered into a profit sharing arrangement with Cobalt
Pharmaceuticals Inc. and Pharmascience Inc. to market certain of our generic products.
European Union. We believe that the evolving European Union generics market has the potential
to provide us with opportunities for substantial growth in our sales. The European Union generics
market varies considerably from country to country. The Netherlands and U.K. have well-established
markets for generic drugs sold under their chemical name. In other European Union countries, there
is a market for branded generics, but not for products sold under their chemical name. In France,
generics have begun to take a firmer hold on the pharmaceutical market. In Italy, within the last
few years legislation that permits generic substitution has been enacted. In July 2002, a law
became effective in Germany, which for the first time allows generic substitution by pharmacists
under certain prescribed circumstances.
Dr. Reddys Laboratories (U.K) Limited, which we acquired in fiscal 2003, is engaged in the
marketing of our generic products in the U.K. and other European Union countries. We currently
market approximately 41 generic products representing over 85 dosage strengths. New product
launches in fiscal 2005 included the generic versions of simvastatin, cetrizine, ramipril,
fluoxetine and ketoconazole liquid. We also seek to expand our presence to the other European
countries either directly or through strategic alliances. Consistent with this strategy, during
fiscal 2005, we commenced sales of generic amlodipine maleate in certain European markets through
an out-licensing arrangement with a partner.
Manufacturing & Materials
As with formulations, generics are packaged in individual doses for consumption by the
patient. In fiscal 2005, our generics segment procured 69.6% of its API requirements from our API
segment
We manufacture most of our finished products at our plant in Andhra Pradesh, India. We have
also acquired manufacturing facilities in the U.K. to supplement our capacities in India. The
facility in Andhra Pradesh, India is designed for the manufacture of tablets, hard gelatin capsules
and soft gelatin capsules. We added large batch size tableting and pellets capabilities in this
facility during fiscal 2003. We are dependent on third parties for the supply of the inactive
pharmaceutical ingredients used in our products.
For our manufacturing operations in India, we source most of the raw material requirements
with respect to the active pharmaceutical ingredients internally from our API division. We are
required to identify the supplier(s) of all the raw materials for our products in the drug
applications that we file with the U.S. FDA. If raw materials for a particular product become
unavailable from an approved supplier specified in a drug application, we would be required to
qualify a substitute supplier with the U.S. FDA, which would likely interrupt manufacturing of the
affected product. To the extent practicable, we attempt to identify more than one supplier in each
drug application. However, some raw materials are available only from a single source and, in some
of our drug applications, only one supplier of raw materials has been identified, even in instances
where multiple sources exist. In addition, we obtain a significant portion of our inactive
pharmaceutical ingredients from foreign suppliers. Arrangements with international raw material
suppliers are subject to, among other things, U.S. FDA regulation, various import duties and other
government clearances.
Our facilities in the U.K. are located at Battersea and Beverley. These facilities currently
serve the requirements of the U.K. market. These facilities are designed for the manufacture and
packaging of pharmaceutical products in a variety of dosage forms, including tablets, capsules,
liquids and creams. All of our U.K. manufacturing operations are subject to stringent regulatory
controls with both facilities subject to regular inspections from the U.K. regulatory bodies. The
facilities hold all relevant licenses and authorizations required to conduct all necessary
activities, including the supply of materials for use in clinical studies. In addition, the quality
systems for ensuring product quality planning and control are ISO 9000 accredited.
For our manufacturing operations in the U.K, we are dependent on third parties for the supply
of all pharmaceutical ingredients and packaging materials used in manufactured products. Supply
agreements are in place with all of our suppliers. We are required to identify the suppliers of key
raw materials, including all active materials used in our products, within our applications to
market products within the U.K. and Europe. If we wish to change to an alternative supplier, then
we are required to substantiate the suitability of the alternative raw materials and seek prior
approval from the health authority in each market where our products using the alternative raw
materials are marketed.
Competition
27
Revenues and gross profit derived from the sales of generic pharmaceutical products are
affected by certain regulatory and competitive factors. As patents and regulatory exclusivity for
brand name products expire, the first off-patent manufacturer to receive regulatory approval for
generic equivalents of such products is generally able to achieve significant market penetration.
As competing off-patent manufacturers receive regulatory approvals on similar products, market
share, revenues and gross profit typically decline, in some cases significantly. Accordingly, the
level of market share, revenues and gross profit attributable to a particular generic product is
normally related to the number of competitors in that products market and the timing of that
products regulatory approval and launch, in relation to competing approvals and launches.
Consequently, we must continue to develop and introduce new products in a timely and cost-effective
manner to maintain our revenues and gross margins. In addition, the other competitive factors
critical to this business include price, product quality, prompt delivery, customer service and
reputation. Many of our competitors seek to participate in sales of generic products by, among
other things, collaborating with other generic pharmaceutical companies or by marketing their own
generic equivalent to their branded products. Our major competitors for the U.S. market include
Ranbaxy Laboratories Limited, Teva Pharmaceutical Industries Limited, Barr Laboratories Inc., Mylan
Laboratories Inc., Andrx Corporation, IVAX Corporation and Sandoz, a division of Novartis Pharma
A.G. Our major competitors for generic products in the European Union include Ranbaxy Laboratories
Limited, Teva Pharmaceutical Industries Limited, IVAX Corporation, Sandoz, a division of Novartis
Pharma A.G., Alpharma Inc., Merck Generics, Pliva d.d., Ratiopharm GmbH, and STADA Arzneimittel
A.G.
Brand-name manufacturers have devised numerous strategies to delay competition from lower cost
generic versions of their products. One of these strategies is to change the dosage form or dosing
regimen of the brand product prior to generic introduction, which may reduce the demand for the
original dosage form as sought by a generic ANDA dossier applicant or create regulatory delays,
sometimes significant, while the generic applicant, to the extent possible, amends its ANDA dossier
to match the changes in the brand product. In many of these instances, the changes to the brand
product may be protected by patent or data exclusivities, further delaying generic introduction.
Another strategy is the launch by the innovator or its licensee of an authorized generic during
the 180-day generic exclusivity period, resulting in two generic products competing for the market
rather than just the product that obtained the generic exclusivity. This may result in reduced
revenues for the generic company, which has been awarded the generic exclusivity period.
Government regulations
U.S. Regulatory Environment
All pharmaceutical manufacturers that sell products in the U.S. are subject to extensive
regulation by the U.S. federal government, principally pursuant to the Federal Food, Drug and
Cosmetic Act, the Hatch-Waxman Act, the Generic Drug Enforcement Act and other federal government
statutes and regulations. These regulations govern or influence the testing, manufacturing,
packaging, labeling, storing, record keeping, safety, approval, advertising, promotion, sale and
distribution of products.
Our facilities and products are periodically inspected by the U.S. FDA, which has extensive
enforcement powers over the activities of pharmaceutical manufacturers. Non-compliance with
applicable requirements can result in fines, criminal penalties, civil injunction against shipment
of products, recall and seizure of products, total or partial suspension of production, sale or
import of products, refusal of the U.S. government to enter into supply contracts or to approve new
drug applications and criminal prosecution. The U.S. FDA also has the authority to deny or revoke
approvals of drug active ingredients and dosage forms and the power to halt the operations of
non-complying manufacturers. Any failure by us to comply with applicable U.S. FDA policies and
regulations could have a material adverse effect on the operations in our generics business.
U.S. FDA approval of an ANDA is required before a generic equivalent of an existing or
referenced brand drug can be marketed. The ANDA process is abbreviated because when processing an
ANDA, the U.S. FDA waives the requirement of conducting complete clinical studies, although it
normally requires bio-availability and/or bio-equivalence studies. An ANDA may be submitted for a
drug on the basis that it is the equivalent of a previously approved drug or, in the case of a new
dosage form, is suitable for use for the indications specified.
An ANDA applicant in the United States is required to review the patents of the innovator
listed in the U.S. F.D.A. publication entitled Approved Drug Products with Therapeutic Equivalence
Evaluations, popularly known as the Orange Book, and make an appropriate certification. There are
several different types of certifications that can be made. A
28
Paragraph IV filing is made when the ANDA applicant believes its product or the use of its
product does not infringe on the innovators patents listed in the Orange Book or where the
applicant believes that such patents are not valid or enforceable. The first generic company to
file a Paragraph IV filing may be eligible to receive a six-month marketing exclusivity period from
the date a court rules the patent is invalid or not infringed. A Paragraph III filing is made when
the ANDA applicant does not intend to market its generic product until the patent expiration. A
Paragraph II filing is made where the patent has already expired. A Paragraph I filing is made when
the innovator has not submitted the required patent information for listing in the Orange Book.
Another type of certification is made where a patent claims a method of use, and the ANDA
applicants proposed label does not claim that method of use. When an innovator has listed more
than one patent in the Orange Book, the ANDA applicant must file separate certifications as to each
patent. Generally, Paragraph IV and Paragraph III filings are made before the product goes off
patent, and Paragraph II and Paragraph I filings are made after the patent has expired.
Before approving a product, the FDA also requires that our procedures and operations conform
to Current Good Manufacturing Practice (cGMP) regulations, relating to good manufacturing
practices as defined in the U.S. Code of Federal Regulations. We must follow cGMP regulations at
all times during the manufacture of our products. We continue to spend significant time, money and
effort in the areas of production and quality testing to help ensure full compliance with cGMP
regulations.
The timing of final U.S. FDA approval of an ANDA depends on a variety of factors, including
whether the applicant challenges any listed patents for the drug and whether the brand-name
manufacturer is entitled to one or more statutory exclusivity periods, during which the U.S. FDA
may be prohibited from accepting applications for, or approving, generic products. In certain
circumstances, a regulatory exclusivity period can extend beyond the life of a patent, and thus
block ANDAs from being approved on the patent expiration date. For example, in certain
circumstances the U.S. FDA may now extend the exclusivity of a product by six months past the date
of patent expiry if the manufacturer undertakes studies on the effect of their product in children,
a so-called pediatric extension.
In June 2003, the U.S. FDA announced reforms in its generic drug review program with the goal
of providing patients with greater and more predictable access to effective, low cost generic
alternatives to brand name drugs.
The Medicare Prescription Drug, Improvement and Modernization Act of 2003 (the Medicare Act
of 2003) has modified certain provisions of the Hatch-Waxman Act. In particular, significant
changes have been made to provisions governing 180-day exclusivity and forfeiture thereof. The new
statutory provisions governing 180-day exclusivity may or may not apply to an ANDA, depending on
whether the first Paragraph IV certification submitted by any applicant for the drug was submitted
prior to the enactment of the Medicare Amendments on December 8, 2003.
Where the first Paragraph IV certification was submitted on or after December 8, 2003, the new
statutory provisions apply. Under these provisions, 180-day exclusivity is awarded to each ANDA
applicant submitting a Paragraph IV certification for the same drug with regard to any patent on
the first day that any ANDA applicant submits a Paragraph IV certification for the same drug. The
180-day exclusivity period begins on the date of first commercial marketing of the drug by any of
the first applicants. However, a first applicant may forfeit its exclusivity in a variety of ways,
including, but not limited to (a) failure to obtain tentative approval within 30 months after the
application is filed or (b) failure to market its drug by the later of two dates calculated as
follows: (x) 75 days after approval or 30 months after submission of the ANDA, whichever comes
first, or (y) 75 days after each patent for which the first applicant is qualified for 180-day
exclusivity is either (1) the subject of a final court decision holding that the patent is invalid,
not infringed, or unenforceable or (2) withdrawn from listing with the U.S. FDA (court decisions,
including settlements, qualify if either the first applicant or any applicant with a tentative
approval is a party; a final court decision is a decision by a court of appeals or a decision by a
district court that is not appealed). The foregoing is an abbreviated summary of certain
provisions of the Medicare Act, and accordingly it should be consulted for a complete understanding
of both the provisions described above and other important provisions related to 180-day
exclusivity and forfeiture thereof.
Where the first Paragraph IV certification was submitted prior to enactment of the Medicare
Act, the statutory provisions governing 180-day exclusivity prior to the Medicare Act still apply.
The U.S. FDA interprets these statutory provisions to award 180-day exclusivity to each ANDA
applicant submitting a Paragraph IV certification for the same drug on the same day with regard to
the same patent on the first day that any ANDA applicant submits a Paragraph IV certification for
the same drug with regard to the same patent. The 180-day exclusivity period begins on the date of
first commercial marketing of the drug by any of the first applicants or on the date of a final
court decision holding that the patent is invalid, not infringed, or unenforceable, whichever comes
first. A final court decision is a decision by a court of
29
appeals, a decision by a district court that is not appealed, or a decision by a district
court prior to the enactment date of the Medicare Act.
The U.S. FDAs interpretation of the pre-Medicare Act statutory provisions has been the
subject of judicial challenge. One district court rejected the agencys interpretation and held
that, under the pre-Medicare Act statutory provisions, 180-day exclusivity is not determined for
each patent but is rather determined for all patents based on the first submission of a Paragraph
IV certification for any patent for the same drug, as is now the case under the Medicare Act
provisions governing 180-day exclusivity. This ruling was dismissed as moot upon appeal and the
U.S. FDA has indicated that it does not intend to change its interpretation.
European Union Regulatory Environment
The activities of pharmaceutical companies within the European Union are governed by Directive
2001/83EC as amended. This Directive outlines the legislative framework, including the legal basis
of approval, specific licensing procedures, and quality standards including manufacture, patient
information and pharmacovigilance activities.
Our U.K. facilities are licensed and periodically inspected by the U.K. MHRA Inspectorate,
which has extensive enforcement powers over the activities of pharmaceutical manufacturers.
Non-compliance can result in product recall and closure. In addition, the U.K. MHRA Inspectorate
has approved and periodically inspected two of our manufacturing facilities based in Andhra
Pradesh, India for the manufacture of generic tablets and capsules for supply to Europe.
Prior approval of a Marketing Authorization is required to supply products within the European
Union. Such Marketing Authorizations may be restricted to one member state then recognized in other
member states or can cover the whole of the European Union, depending upon the form of registration
elected.
Generic or abridged applications are abridged by the omission of full non-clinical and
clinical data but may contain limited non-clinical and clinical data, depending upon the legal
basis of the application or to address a specific issue. The majority of our generic applications
are made on the basis of essential similarity although other criteria may be applied. In the case
of an essentially similar application, the applicant is required to demonstrate that its generic
product contains the same active pharmaceutical ingredients in the same dosage form for the same
indication as the innovator product. Specific data is included in the application to demonstrate
that the proposed generic product is essentially similar to the innovator product with respect to
quality, safe usage and continued efficacy. The applicant is also required to demonstrate
bioequivalence with the referenced product. Once all these criteria are met then a Marketing
Authorization may be considered for grant.
Unlike the U.S., there is no regulatory mechanism within the European Union to challenge any
patent protection. Nor is any period of market exclusivity conferred upon the first generic
approval. In situations where the period of exclusivity given to the branded product expires
before their patent expiry, the launch of our product would then be delayed until patent expiry.
Canada and South Africa Regulatory Environment
In Canada and South Africa, we are required to file product dossiers with the particular
countrys regulatory authority for permission to market the generic formulation. The regulatory
authorities may inspect our manufacturing facility before approval of the dossier.
30
Critical Care and Biotechnology Segment
The critical care and biotechnology businesses were started in 1998 to focus on and create a
strong technology base in these areas. While this area of our business generates low sales volume,
the products are generally high value. Our critical care products are formulations used in
hospitals to treat cancer and for supportive care. Our biotechnology products cover recombinant
protein therapeutics development. The trading operations of our diagnostics division were
discontinued in fiscal 2004.
The following table provides revenues for this segment for fiscal 2003, 2004 and 2005
respectively:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal Year Ended March 31, |
|
|
2003 |
|
2004 |
|
2005 |
Division |
|
Revenues |
|
% Total |
|
Revenues |
|
% Total |
|
Revenues |
|
|
% Total |
|
|
(in millions) |
|
|
|
|
|
(in millions) |
|
|
|
|
|
(in millions) |
|
|
|
Critical Care |
|
Rs. |
235.5 |
|
|
|
55.0 |
% |
|
Rs. |
325.2 |
|
|
|
79.1 |
% |
|
Rs. |
407.9 |
|
|
|
U.S.$9.3 |
|
|
|
77.4 |
% |
Diagnostics |
|
|
136.8 |
|
|
|
31.9 |
|
|
|
9.1 |
|
|
|
2.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Biotechnology |
|
|
55.9 |
|
|
|
13.1 |
|
|
|
76.7 |
|
|
|
18.7 |
|
|
|
119.2 |
|
|
|
2.7 |
|
|
|
22.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
Rs. |
428.2 |
|
|
|
100.0 |
% |
|
Rs. |
411.0 |
|
|
|
100.0 |
% |
|
Rs. |
527.1 |
|
|
|
U.S.$12.0 |
|
|
|
100.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table sets forth revenues of our critical care and biotechnology segment by
geographic area for fiscal 2003, 2004 and 2005 respectively:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal Year Ended March 31, |
|
|
2003 |
|
2004 |
|
2005 |
Division |
|
Revenues |
|
% Total (1) |
|
Revenues |
|
% Total (1) |
|
Revenues |
|
|
% Total (1) |
|
|
(in millions) |
|
|
|
|
|
(in millions) |
|
|
|
|
|
(in millions) |
|
|
|
|
|
India |
|
Rs. |
378.0 |
|
|
|
88.3 |
% |
|
Rs. |
259.5 |
|
|
|
63.1 |
% |
|
Rs. |
360.7 |
|
|
|
U.S.$8.3 |
|
|
|
68.4 |
% |
Russia |
|
|
14.4 |
|
|
|
3.4 |
|
|
|
39.5 |
|
|
|
9.6 |
|
|
|
62.3 |
|
|
|
1.4 |
|
|
|
11.8 |
|
Other CIS(2) |
|
|
1.2 |
|
|
|
0.2 |
|
|
|
12.2 |
|
|
|
3.0 |
|
|
|
19.4 |
|
|
|
0.4 |
|
|
|
3.7 |
|
Other |
|
|
34.6 |
|
|
|
8.1 |
|
|
|
99.8 |
|
|
|
24.3 |
|
|
|
84.7 |
|
|
|
1.9 |
|
|
|
16.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
Rs. |
428.2 |
|
|
|
100.0 |
|
|
Rs. |
411.0 |
|
|
|
100.0 |
|
|
Rs. |
527.1 |
|
|
|
U.S.$12.1 |
|
|
|
100.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Refers to our revenues from market sales in the applicable country expressed as a percentage of
our total revenues throughout the world. |
|
(2) |
|
Other CIS refers to other countries in the Commonwealth of Independent States, countries of
the former Soviet Union. |
Critical care. This business accounted for 77.4% of the segments revenues in fiscal
2005, contributing Rs.407.9 million. We focus on high margin, low volume products for niche markets
in India in the area of critical care. Our main products are Mitotax (paclitaxel), Cytogem
(gemcitabine), Docetere (docetaxel) and Irinocam (irinotecan). We also market Dacotin
(oxaliplatin), which is licensed and imported from Debiopharm S.A. of Switzerland. In fiscal 2005
we launched 3 new products Capiibine (capecitabine), Blaztere (zoledronic acid) and Thaangio
(thalidomide).
The following table sets forth the sales of our key products in fiscal 2003, 2004 and 2005:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal Year Ended March 31, |
|
|
Therapeutic |
|
2003 |
|
2004 |
|
2005 |
Product |
|
Category |
|
Revenues |
|
% Total(1) |
|
Revenues |
|
% Total(1) |
|
Revenues |
|
|
% Total(1) |
|
|
|
|
(in millions) |
|
|
|
|
|
(in millions) |
|
|
|
|
|
(in millions) |
|
|
|
|
|
Mitotax |
|
Ovarian/breast/lung cancer |
|
|
Rs.83.0 |
|
|
|
35.3 |
% |
|
Rs. |
123.8 |
|
|
|
38.0 |
% |
|
Rs. |
178.8 |
|
|
|
U.S.$4.1 |
|
|
|
43.8 |
% |
Docetere |
|
Breast/lung cancer |
|
|
37.6 |
|
|
|
15.9 |
|
|
|
77.0 |
|
|
|
23.7 |
|
|
|
73.2 |
|
|
|
1.7 |
|
|
|
17.9 |
|
Cytogem |
|
Lung/pancreatic cancer |
|
|
38.2 |
|
|
|
16.2 |
|
|
|
63.3 |
|
|
|
19.5 |
|
|
|
59.1 |
|
|
|
1.4 |
|
|
|
14.5 |
|
Dacotin |
|
Colorectal cancer |
|
|
27.3 |
|
|
|
11.6 |
|
|
|
16.4 |
|
|
|
5.0 |
|
|
|
25.9 |
|
|
|
0.6 |
|
|
|
6.3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
Rs.186.1 |
|
|
|
79.0 |
% |
|
Rs. |
280.5 |
|
|
|
86.2 |
% |
|
Rs. |
337.2 |
|
|
|
U.S.$7.8 |
|
|
|
82.7 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Refers to our revenues from sales of the applicable product expressed as a percentage of the
total revenues of our critical care and biotechnology segment. |
Biotechnology. Our biotechnology portfolio is currently comprised of Grastim, the
bio-generic version of filgrastim, the human Granulocyte Colony Stimulating Factor (hG-CSF).
Filgrastim is a recombinant protein used in chemotherapy-induced neutropenia and in bone marrow
transplantation. We were the first company in India to fully develop in-house, from the molecular
biology stage to production, the biogeneric Grastim. We developed Grastim for launch in India
followed by other international markets.
31
Our biotechnology pipeline consists of biogenerics and variants of existing molecules,
including several recombinant proteins in mammalian cell culture as well as E.Coli, all in various
phases of development.
We view biotechnology as a business with significant potential. Our commitment to the business
is reflected in our investments in building the research and development infrastructure as well as
scientific teams. Our research and development facility caters to the highest development
standards, including cGMP, Good Laboratory Practices and bio-safety level IIA. We are in the
process of building our bio-generics pipeline. We have an agreement with a U.S. based biotechnology
company for the development of bio-generics.
Sales, Marketing and Distribution Network.
The marketing of our critical care and biotechnology products is handled by a dedicated sales
and marketing team. We sell our products through clearing and forwarding agents in India. In India,
the marketing team promotes our products to medical specialists and focuses on sales to hospitals,
government agencies, non-government institutional organizations and pathology laboratories.
We also have a partnership agreement with Pliva d.d., an Eastern European generics company,
for the development and marketing of a group of oncology products for the European markets.
Manufacturing and Materials
For our critical care products, we manufacture most of the active pharmaceutical ingredients.
The manufacturing of the formulation is undertaken at our formulations facility. We source some of
the products from third party suppliers. We have commissioned a completely contained API facility
for the manufacture of cytotoxic products. We are in the process of establishing an API facility
for hormonal products. We are also in the process of establishing a facility in Visakhapatnam,
India for the manufacture of oral solid dosage form and injectable forms of cytotoxic as well as
hormonal products.
We have a facility at Bachupalli, Andhra Pradesh, India for the manufacture of our
biotechnology products. The manufacture of our biotechnology products involves cloning proteins in
bacteria and then extracting the proteins from the bacteria by fermentation and purification. The
facility is equipped with a cell culture laboratory for evaluation of products as well as a
facility for studies of compounds and provision for the safe disposal of wastes and effluents.
Competition
For our critical care products, our main competitors in the oncology market in India are Dabur
Pharma Limited, Cipla Limited, Eli Lily & Co. and Aventis India Limited. For the range of oncology
products currently under development, our main competitors include generics companies in India,
Europe and the U.S. with a focus on development of oncology products, including Mayne Group Limited
(Australia), Zydus Cadila Group (India) and Pliva d.d. (Croatia).
In our biotechnology business, our marketed product faces competition primarily from the
innovator company. Given the significant potential of the biogenerics market, several companies are
focused on the development of biogenerics, including Barr Laboratories Inc. and Pliva d.d.
Government Regulations
For critical care products, the regulations are similar to those as discussed in the
formulations, API and generics segments.
The biotechnology sector in India is governed by the guidelines/rules formulated by the
Department of Biotechnology (DBT), under the Indian governments Ministry of Science &
Technology. The guidelines cover the entire requirements of various other related
ministries/statutory departments of the government of India.
A business which intends to manufacture and market biotechnology products is required to form
an Institutional Bio Safety Committee (IBSC) consisting of internal experts on related fields as
well as a nominee of the DBT and Central Pollution Control Board (CPCB). The IBSC reviews,
verifies and approves the product application before submitting it to the Review Committee of
Genetic Manipulation (RCGM) under the Indian governments Ministry of Science &
32
Technology. The RCGM verifies and approves all the data included in the application including
the protocol and final reports on animal toxicity and human clinical trials.
Once clearance on all the related issues is obtained from RCGM, the business needs to obtain
clearance from the Genetic Engineering Approval Committee (GEAC) under the Ministry of
Environment and Forest, Government of India. The GEAC forwards its recommendation to the DBT and
DCGI. Based on receipt of a No Objection Certificate from DCGI, the business has to obtain
manufacturing license from the State Drugs Authority and thereafter can commence commercial
marketing.
Drug Discovery Segment
Drug discovery is a key segment of our business. In this segment, we are actively pursuing
discovery and development of Novel Chemical Entities (NCEs). Our research programs focus on the
following therapeutic areas:
|
§ |
|
Metabolic disorders |
|
|
§ |
|
Cardiovascular disorders |
|
|
§ |
|
Cancer |
|
|
§ |
|
Bacterial infections |
Our research laboratories are based in Hyderabad, India and Atlanta, Georgia, U.S. As of March
31, 2005, we employed a total of 310 scientists, including approximately 59 scientists who held
Ph.D. degrees. We pursue an integrated research strategy with our laboratories in the United
States focusing on discovery of new molecular targets and designing of screening assays to screen
for promising lead molecules followed by selection and optimization of lead molecules and further
clinical development of those optimized leads at our laboratories in India. By establishing a
research facility in the United States, we have better access to research scientists in the United
States, enhancing our screening abilities for new molecular targets and access to high technology
platforms
While we continue to seek licensing and development arrangements with third parties to further
develop our pipeline products, we also conduct clinical development of some of the candidate drugs
ourselves where it is economically and technically feasible. Our long-term strategy for drug
discovery is to increasingly undertake clinical testing ourselves, as we believe that this will
enable us to derive higher value for our compounds. Our goal is to balance internal development of
our own product candidates with in-licensing of promising compounds that complement our strengths.
We also pursue licensing and joint development of some of our lead compounds with companies looking
to implement their own product portfolio. DRF 10945 is our drug candidate in the metabolic
disorder segment, which is being developed for the treatment of high triglycerides and low HDL
cholesterol. We have completed Phase I studies in Canada and are preparing to move this compound
forward into Phase II-a trials in Canada. RUS 3108 is our drug candidate in the cardiovascular
segment, which is being developed for the treatment of atherosclerosis. We have completed Phase I
single ascending dose trials in Belfast, Ireland for RUS 3108 and we plan to initiate Phase I
multiple ascending dose studies in Belfast, Ireland.
As part of our research program, we pursue collaborations with leading institutions and
laboratories all over the world. We enter into these collaborations to utilize the expertise and
facilities these institutions and laboratories provide. We have collaborated with the National
Cancer Institute in Maryland, which is a part of the United States National Institutes of Health.
We have also entered into collaboration agreements with the National Cancer Institute for the
screening of anti-cancer compounds.
Our investments into research and development of NCEs have been consistently focused towards
developing promising therapeutics. In fiscal 2003, 2004 and 2005, we spent Rs.480.1 million,
Rs.729.4 million and Rs.868.9 million respectively, towards drug discovery activities. In fiscal
2003, 2004 and 2005, we received Rs.0, Rs.0, and Rs.288.4 million respectively in revenues from
drug discovery activities.
As of March 31, 2005, the compounds under development in our pipeline included:
|
|
|
|
|
Compound |
|
Therapeutic Area |
|
Development Status |
DRF 2593
|
|
Metabolic disorders
|
|
Phase II completed |
|
|
|
|
|
DRF 10945
|
|
Metabolic disorders
|
|
Phase I clinical trials in Canada completed |
|
|
|
|
|
DRF 11605
|
|
Metabolic disorders
|
|
Pre-clinical; Good Laboratory Practice toxicity studies in progress |
|
|
|
|
|
DRF 1042
|
|
Cancer
|
|
Phase II clinical trials in progress in India (Diastereomeric mixture) |
|
|
|
|
Phase I clinical trials in progress in India (single isomer) |
33
|
|
|
|
|
Compound |
|
Therapeutic Area |
|
Development Status |
RUS 3108
|
|
Cardiovascular
|
|
Phase I clinical trials in progress in Europe |
|
|
|
|
|
DRF 13792
|
|
Bacterial infections
|
|
Pre-clinical; Good Laboratory Practice toxicity studies in progress |
Patents. The status of patents filed and issued as of March 31, 2005 is summarized below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Metabolic |
|
|
|
|
|
Bacterial |
|
|
|
|
|
|
|
|
|
|
Disorders |
|
Cancer |
|
Infections |
|
Inflammation |
|
Cardiovascular |
|
Others |
|
Total |
U.S. filed |
|
|
60 |
|
|
|
12 |
|
|
|
7 |
|
|
|
2 |
|
|
|
0 |
|
|
|
0 |
|
|
|
81 |
|
U.S. issued |
|
|
32 |
|
|
|
7 |
|
|
|
0 |
|
|
|
2 |
|
|
|
0 |
|
|
|
0 |
|
|
|
41 |
|
PCT filed(1) |
|
|
56 |
|
|
|
12 |
|
|
|
7 |
|
|
|
2 |
|
|
|
0 |
|
|
|
3 |
|
|
|
80 |
|
India filed |
|
|
97 |
|
|
|
41 |
|
|
|
20 |
|
|
|
11 |
|
|
|
1 |
|
|
|
22 |
|
|
|
192 |
|
India issued |
|
|
16 |
|
|
|
10 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
8 |
|
|
|
34 |
|
(1) PCT means the Patent Cooperation Treaty, an international treaty that
facilitates foreign patent filings for residents of member countries when obtaining patents in
other member countries.
Stages of Testing / Development. The stages of testing required before a pharmaceutical
product can be marketed in the United States are generally as follows:
|
|
|
Stage of Development |
|
Description |
Preclinical
|
|
Animal studies and laboratory tests to evaluate safety and efficacy,
demonstrate activity of a product candidate and identify its chemical and
physical properties. |
|
|
|
Phase I
|
|
Clinical studies to test safety and pharmacokinetic profile of a drug in humans. |
|
|
|
Phase II
|
|
Clinical studies conducted with groups of patients to determine preliminary
efficacy, dosage and expanded evidence of safety. |
|
|
|
Phase III
|
|
Larger scale clinical studies conducted in patients to provide sufficient data
for statistical proof of efficacy and safety. |
For ethical, scientific and legal reasons, animal studies are required in the discovery and
safety evaluation of new medicines. Preclinical tests assess the potential safety and efficacy of a
product candidate in animal models. The results of these studies must be submitted to the U.S. FDA
as part of a NDA before human testing may proceed.
U.S. law further requires that studies conducted to support approval for product marketing be
adequate and well controlled. In general, this means that either a placebo or a product already
approved for the treatment of the disease or condition under study must be used as a reference
control. Studies must also be conducted in compliance with good clinical practice requirements, and
adverse event and other reporting requirements must be followed.
The clinical trial process can take five to ten years or more to complete, and there can be no
assurance that the data collected will be in compliance with good clinical practice regulations,
will demonstrate that the product is safe or effective, or, in the case of a biologic product, pure
and potent, or will provide sufficient data to support U.S. FDA approval of the product. The U.S.
FDA may place clinical trials on hold at any point in this process if, among other reasons, it
concludes that clinical subjects are being exposed to an unacceptable health risk. Trials may also
be terminated by institutional review boards, who must review and approve all research involving
human subjects. Side effects or adverse events that are reported during clinical trials can delay,
impede, or prevent marketing authorization.
34
Scientific Advisory Board. Our Scientific Advisory Board is composed of seven leading
professionals in the field of healthcare and chemical sciences. These professionals contribute to
the strategic definition and implementation of pre-clinical development plans for our products.
Members of the advisory committee meet individually and as a group with our management on an annual
basis.
|
|
|
Dr. K. Anji Reddy
|
|
Chairman, Dr. Reddys Laboratories Limited |
|
|
|
Dr. R. Rajagopalan
|
|
President, Discovery Research, Dr. Reddys Laboratories Limited |
|
|
|
Dr. V. Mohan
|
|
Managing Director, M.V. Diabetes Specialties Center (P) Limited, Madras |
|
|
|
Dr. K. Janardhan Reddy
|
|
Professor and Chairman, Department of Pathology, Northwestern University Medical School,
Chicago, Illinois, U.S.A. |
|
|
|
Dr. Sampath Parthasarthy
|
|
Director, Division of Research, Emory University School of Medicine, Atlanta, Georgia, U.S.A. |
|
|
|
Dr. Henry Ginsberg
|
|
Herbert Irving Professor of Medicine, Division of Preventive Medicine, Presbyterian
Hospital, New York, U.S.A. |
|
|
|
Dr. Ira J. Goldberg
|
|
Professor of Medicine, Division of Preventive Medicine and Nutrition Columbia University
College of Physicians and Surgeons, New York, U.S.A. |
|
|
|
Dr. Uday Saxena
|
|
Chief Scientific Officer, Dr.Reddys Laboratories Limited
|
|
|
|
Dr. Daniel Rader
|
|
Faculty in the Department of Medicine and the Director of Cardiovascular Metabolism unit at the Institute for Diabetes, Obesity and Metabolism, University of Pennsylvania |
Competition
The pharmaceutical and biotechnology industries are highly competitive. We face intense
competition from organizations such as large pharmaceutical companies, biotechnology companies and
academic and research organizations. The major pharmaceutical organizations competing with us have
greater capital resources, larger overall research and development staff and facilities and
considerably more experience in drug development. Biotechnology companies competing with us may
have these advantages as well. In addition to competition for collaborators and investors, these
companies and institutions also compete with us in recruiting and retaining highly qualified
scientific and management personnel.
Government regulations
Virtually all pharmaceutical and biotechnology products that we or our collaborative partners
develop will require regulatory approval by governmental agencies prior to commercialization. The
nature and extent to which these regulations apply varies depending on the nature of the products
and also vary from country to country. In particular, human pharmaceutical products are subject to
rigorous pre-clinical and clinical testing and other approval procedures by the relevant regulatory
agency. The requirements governing the conduct of clinical trials, product licensing, pricing and
reimbursement vary widely from country to country.
In India, under the Drugs and Cosmetics Act, 1940, the regulation of the manufacture, sale and
distribution of drugs is primarily the concern of the state authorities while the Central Drug
Control Administration is responsible for approval of new drugs, clinical trials in the country,
laying down the standards for drugs, control over the quality of imported drugs, coordination of
the activities of state drug control organizations and providing expert advice with a view of
bringing about the uniformity in the enforcement of the Drugs and Cosmetics Act, 1940.
For marketing a drug in the United States, we or our partners will be subject to regulatory
requirements governing human clinical trials, marketing approval and post-marketing activities for
pharmaceutical products and biologics. Various federal and, in some cases, state statutes and
regulations also govern or influence the manufacturing, safety, labeling, storage, record-keeping
and marketing of these products. The process of obtaining these approvals and the subsequent
compliance with applicable statutes and regulations is time consuming and requires substantial
resources, and the approval outcome is uncertain.
Generally, in order to gain U.S. FDA approval, a company first must conduct pre-clinical
studies in the laboratory and in animal models to gain preliminary information on a compounds
activity and to identify any safety problems. Pre-clinical studies must be conducted in accordance
with U.S. FDA regulations. The results of these studies are submitted as a part of an
Investigational New Drug (IND) application that the U.S. FDA must review before human clinical
trials of an investigational drug can start. If the U.S. FDA does not respond with any questions, a
drug developer can commence clinical trials thirty days after the submission of an IND.
In order to eventually commercialize any products, we or our collaborator first will be
required to sponsor and file an IND and will be responsible for initiating and overseeing the
clinical studies to demonstrate the safety and efficacy that are necessary to obtain U.S. FDA
marketing approval. Clinical trials are normally done in three phases and generally take several
years, but may take longer to complete. The clinical trials have to be designed taking into account
the applicable
35
U.S. FDA guidelines. Furthermore, the U.S. FDA may suspend clinical trials at any time if the
U.S. FDA believes that the subjects participating in trials are being exposed to unacceptable risks
or if the U.S. FDA finds deficiencies in the conduct of the trials or other problems with our
product under development.
After completion of clinical trials of a new product, U.S. FDA marketing approval must be
obtained. If the product is classified as a new pharmaceutical, we or our collaborator will be
required to file a New Drug Application (NDA), and receive approval before commercial marketing
of the drug. The testing and approval processes require substantial time and effort. NDAs submitted
to the U.S. FDA can take several years to obtain approval and the U.S. FDA is not obligated to
grant approval at all.
Even if U.S. FDA regulatory clearances are obtained, a marketed product is subject to
continual review. If and when the U.S. FDA approves any of our or our collaborators products under
development, the manufacture and marketing of these products will be subject to continuing
regulation, including compliance with cGMP, adverse event reporting requirements and prohibitions
on promoting a product for unapproved uses. Later discovery of previously unknown problems or
failure to comply with the applicable regulatory requirements may result in restrictions on the
marketing of a product or withdrawal of the product from the market as well as possible civil or
criminal sanctions. Various federal and, in some cases, state statutes and regulations also govern
or influence the manufacturing, safety, labeling, storage, record keeping and marketing of
pharmaceutical products.
Our research and development processes involve the controlled use of hazardous materials and
controlled substances. We are subject to federal, state and local laws and regulations governing
the use, manufacture, storage, handling and disposal of these materials and waste products.
4.C. Organizational structure
Dr. Reddys Laboratories Limited is the parent company in our group. We had the following
subsidiary companies as of March 31, 2005:
|
|
|
|
|
|
|
|
|
|
|
Percentage of |
|
|
|
|
Direct/ Indirect |
|
|
Country of |
|
Ownership |
Name of Subsidiary |
|
Incorporation |
|
Interest |
DRL Investments Limited |
|
India |
|
|
100 |
% |
Reddy Pharmaceuticals Hong Kong Limited |
|
Hong Kong |
|
|
100 |
% |
OOO JV Reddy Biomed Limited |
|
Russia |
|
|
100 |
% |
Reddy Antilles N.V. |
|
Netherlands |
|
|
100 |
% |
Reddy Netherlands B.V. |
|
Netherlands |
|
|
100 |
%(1) |
Reddy US Therapeutics, Inc. |
|
U.S.A. |
|
|
100 |
%(1) |
Dr. Reddys Laboratories, Inc. |
|
U.S.A. |
|
|
100 |
% |
Dr. Reddys Farmaceutica do Brasil Ltda |
|
Brazil |
|
|
100 |
% |
Cheminor Investments Limited |
|
India |
|
|
100 |
% |
Aurigene Discovery Technologies Limited |
|
India |
|
|
100 |
% |
Aurigene Discovery Technologies, Inc. |
|
U.S.A. |
|
|
100 |
%(3) |
Kunshan Rotam Reddy Pharmaceutical Co. Limited |
|
China |
|
|
51.2 |
%(4) |
Dr. Reddys Laboratories (EU) Limited |
|
United Kingdom |
|
|
100 |
% |
Dr. Reddys Laboratories (U.K.) Limited |
|
United Kingdom |
|
|
100 |
%(5) |
Dr. Reddys Laboratories (Proprietary) Limited |
|
South Africa |
|
|
60 |
% |
Reddy Cheminor S.A.(2) |
|
France |
|
|
100 |
%(2) |
OOO Dr. Reddys Laboratories Limited |
|
Russia |
|
|
100 |
% |
AMPNH Inc. |
|
U.S.A. |
|
|
100 |
%(6) |
Dr. Reddys Bio-sciences Limited |
|
India |
|
|
100 |
% |
Reddy Pharmaceuticals, Inc. |
|
U.S.A. |
|
|
100 |
%(6) |
Trigenesis Therapeutics, Inc. |
|
U.S.A. |
|
|
100 |
% |
|
|
|
(1) |
|
Indirectly owned through Reddy Antilles N.V. |
|
(2) |
|
Subsidiary under liquidation. |
|
(3) |
|
Indirectly owned through Aurigene Discovery Technologies Limited. |
|
(4) |
|
Kunshan Rotam Reddy is a subsidiary as we hold a 51.2 % stake in it; however, we account for
this investment by the equity method and do not consolidate it in our financial statements. |
|
(5) |
|
Indirectly owned through Dr. Reddys Laboratories (EU) Limited |
|
(6) |
|
Indirectly owned through Dr. Reddys Laboratories Inc. |
4.D. Property, plant and equipment
36
The following table sets forth current information relating to our principal facilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Approximate |
|
Built up |
|
|
Location |
|
Area |
|
Area |
|
Certification |
|
|
(Square feet) |
|
(Square feet) |
|
|
|
Active Pharmaceutical Ingredients and Intermediates |
|
|
|
|
|
|
|
|
|
|
Bollaram, Andhra Pradesh, India |
|
|
734,013 |
|
|
|
172,879 |
|
|
U.S. FDA |
Bollaram, Andhra Pradesh, India |
|
|
648,173 |
|
|
|
282,220 |
|
|
U.S. FDA |
Bollaram, Andhra Pradesh, India |
|
|
285,235 |
|
|
|
210,630 |
|
|
U.S. FDA |
Jeedimetla, Andhra Pradesh, India |
|
|
228,033 |
|
|
|
74,270 |
|
|
U.S. FDA |
Miryalguda, Andhra Pradesh, India |
|
|
2,787,840 |
|
|
|
261,734 |
|
|
U.S. FDA |
Pydibheemavaram, Andhra Pradesh, India |
|
|
8,523,466 |
|
|
|
717,886 |
|
|
U.S. FDA |
Pydibheemavaram, Andhra Pradesh, India (5) |
|
|
737,134 |
|
|
|
53,854 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Formulations |
|
|
|
|
|
|
|
|
|
|
Bollaram, Andhra Pradesh, India |
|
|
217,729 |
|
|
|
116,197 |
|
|
(1) |
Bachupalli, Andhra Pradesh, India |
|
|
1,306,372 |
|
|
|
175,388 |
|
|
(2) |
Yanam, Pondicherry, India |
|
|
457,000 |
|
|
|
26,226 |
|
|
None |
Goa, India |
|
|
295,336 |
|
|
|
183,202 |
|
|
(3) |
|
|
|
|
|
|
|
|
|
|
|
Generics |
|
|
|
|
|
|
|
|
|
|
Bachupalli, Andhra Pradesh, India |
|
|
783,823 |
|
|
|
200,134 |
|
|
(4) |
Battersea, London, United Kingdom (6) |
|
|
17,000 |
|
|
|
10,000 |
|
|
U.K. Medicine Control Agency |
Beverley, East Yorkshire, United Kingdom |
|
|
64,904 |
|
|
|
15,179 |
|
|
U.K. Medicine |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Control Agency, ISO 9001: 2000 |
Critical Care and Biotechnology |
|
|
|
|
|
|
|
|
|
|
Bachupalli, Andhra Pradesh, India |
|
|
174,183 |
|
|
|
98,981 |
|
|
None |
|
|
|
|
|
|
|
|
|
|
|
Drug Discovery |
|
|
|
|
|
|
|
|
|
|
Miyapur, Andhra Pradesh, India |
|
|
576,941 |
|
|
|
234,591 |
|
|
None |
Georgia, United States (6) |
|
|
24,733 |
|
|
|
24,733 |
|
|
None |
|
|
|
(1) |
|
Ministry of Health, Sudan; Ministry of Health, Uganda; ANVISA, Brazil; National Medicines
Agency, Romania. |
|
(2) |
|
Medicine Control Council, Republic of South Africa; The State Company for Marketing Drugs and
Medical Appliances, Ministry of Health, Iraq; Sultanate of Oman, Ministry of Health, Muscat;
Ministry of Health, Sudan; Ministry of Health, State of Bahrain; State Pharmaceutical
Inspection, Republic of Latvia; Pharmaceutical and Herbal Medicines, Registration and Control
Administrations, Ministry of Health, Kuwait; National Medicines Agency, Romania; ANVISA,
Brazil; Medicines and Health Care Products Regulatory Agencies (MHRA), U.K. |
|
(3) |
|
National Medicines Agency, Romania; National Drug Authority, Uganda. |
|
(4) |
|
U.S. FDA; Medicines and Healthcare Products Regulatory Agency, U.K.; Ministry of Health,
UAE; Medicines Control Council, South Africa; ANVISA, Brazil ; Environmental Management
System ISO 14001; Occupational Health and Safety Management System OHSAS 18001; Quality
Management System-ISO 9001:2000. |
|
(5) |
|
Export Oriented Unit. |
|
(6) |
|
Leased facilities. |
Except as indicated in the notes above, we own all of our facilities. All properties
mentioned above including leased properties are either used for manufacturing and packaging of
pharmaceutical products or for research and development activities. In addition, we have sales,
marketing and administrative offices, which are leased properties. We believe that our facilities
are optimally utilized.
We are in the process of establishing a facility to manufacture hormonal oncology APIs at
Visakhapatnam, Andhra Pradesh, India. We are also in the process of establishing a facility to
manufacture oral solid and injectable forms of cytotoxic and hormonal formulations at a Special
Economic Zone located in Visakhapatnam.
During fiscal 2005, we initiated the construction of a new facility for the manufacture of
formulations at Baddi, Himachal Pradesh, India to take advantage of certain financial benefits,
which include exemption from income tax and excise duty for a specified period, offered by the
government of India to encourage industrial growth in the state of Himachal Pradesh.
We have working capital facilities with banks and, in order to secure those facilities, we
have created encumbrance charges on certain of our immovable and movable properties.
37
We are subject to significant national and state environmental laws and regulations which
govern the discharge, emission, storage, handling and disposal of a variety of substances that may
be used in or result from our operations at the above facilities. Non-compliance with the
applicable laws and regulations may subject us to penalties and may also result in the closure of
our facilities.
ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS
We are an emerging global pharmaceutical company with proven research capabilities. We produce
active pharmaceutical ingredients and finished dosage forms and biotechnology products and market
them globally, with a focus on India, the United States, Europe and Russia. We conduct basic
research in the areas of cancer, diabetes, cardiovascular disease, inflammation and bacterial
infection.
Our revenues for fiscal 2005 were Rs.19,471.9 million (U.S.$446.4 million). We derived 34.4%
of these revenues from sales in India, 22.3% from North America, 14.3% from Russia and other
countries of the former Soviet Union, 14.7% from Europe and 14.3% from other countries. Our net
income during the same period was Rs.211.2 million (U.S.$4.8 million).
As of March 31, 2005, our business segments are as follows:
|
|
|
Formulations; |
|
|
|
|
Active pharmaceutical ingredients and intermediates; |
|
|
|
|
Generics; |
|
|
|
|
Critical care and biotechnology; and |
|
|
|
|
Drug discovery. |
We discontinued the trading operations in our diagnostics division in fiscal 2004.
5.A. Operating results
Financial Data
The following table sets forth, for the periods indicated, our consolidated net operating
revenues by segment:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal
Year Ended March 31, |
Segment |
|
2003 |
|
2004 |
|
2005 |
|
2005 |
|
|
|
|
|
|
(Rs. in millions, U.S.$ in thousands) |
|
|
|
|
Formulations |
|
|
Rs.6,860.4 |
|
|
|
Rs.7,507.5 |
|
|
|
Rs.7,822.9 |
|
|
U.S.$ |
159,205.1 |
|
Active pharmaceutical ingredients
and intermediates |
|
|
6,340.7 |
|
|
|
7,628.5 |
|
|
|
6,944.5 |
|
|
|
179,342.3 |
|
Generics |
|
|
4,284.2 |
|
|
|
4,337.5 |
|
|
|
3,577.4 |
|
|
|
82,013.3 |
|
Critical care and biotechnology |
|
|
428.2 |
|
|
|
411.0 |
|
|
|
527.1 |
|
|
|
12,084.1 |
|
Drug discovery |
|
|
|
|
|
|
|
|
|
|
288.4 |
|
|
|
6,611.2 |
|
Others |
|
|
156.3 |
|
|
|
196.7 |
|
|
|
311.6 |
|
|
|
7,143.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
Rs.18,069.8 |
|
|
|
Rs.20,081.2 |
|
|
|
Rs.19,471.9 |
|
|
U.S.$ |
446,399.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table sets forth, for the periods indicated, financial data as percentages
of total revenues and the increase (or decrease) by item as a percentage of the amount over the
previous year. Cost of revenues and gross profit by segment are shown as a percentage of that
segments revenues.
38
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage of Revenues |
|
Percentage Increase |
|
|
Fiscal
Year Ended March 31, |
|
(Decrease) |
|
|
2003 |
|
2004 |
|
2005 |
|
2003 to 2004 |
|
2004 to 2005 |
Income Statement Data: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues by segment: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Formulations |
|
|
38.0 |
% |
|
|
37.4 |
% |
|
|
40.2 |
% |
|
|
9.4 |
% |
|
|
4.2 |
% |
Active pharmaceutical ingredients
and intermediates |
|
|
35.1 |
|
|
|
38.0 |
|
|
|
35.7 |
|
|
|
20.3 |
|
|
|
(9.0 |
) |
Generics |
|
|
23.7 |
|
|
|
21.6 |
|
|
|
18.4 |
|
|
|
1.2 |
|
|
|
(17.5 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Critical care and biotechnology |
|
|
2.4 |
|
|
|
2.0 |
|
|
|
2.7 |
|
|
|
(4.0 |
) |
|
|
28.2 |
|
Drug discovery |
|
|
|
|
|
|
|
|
|
|
1.5 |
|
|
|
|
|
|
|
|
|
Other |
|
|
0.8 |
|
|
|
1.0 |
|
|
|
1.5 |
|
|
|
25.8 |
|
|
|
58.4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
100.0 |
|
|
|
100.0 |
|
|
|
100.0 |
|
|
|
11.1 |
|
|
|
(3.0 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenues by segment: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Formulations |
|
|
35.9 |
|
|
|
34.5 |
|
|
|
31.9 |
|
|
|
5.1 |
|
|
|
(3.6 |
) |
Active pharmaceutical ingredients
and intermediates |
|
|
62.1 |
|
|
|
66.9 |
|
|
|
72.2 |
|
|
|
29.5 |
|
|
|
(1.7 |
) |
Generics |
|
|
24.8 |
|
|
|
30.5 |
|
|
|
45.3 |
|
|
|
24.9 |
|
|
|
22.3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Critical care and biotechnology |
|
|
54.7 |
|
|
|
50.4 |
|
|
|
33.5 |
|
|
|
(11.7 |
) |
|
|
(14.7 |
) |
Drug discovery |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other |
|
|
98.3 |
|
|
|
63.9 |
|
|
|
26.5 |
|
|
|
(18.1 |
) |
|
|
(34.4 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total cost of
Revenues |
|
|
43.4 |
|
|
|
46.5 |
|
|
|
48.2 |
|
|
|
19.1 |
|
|
|
0.4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit by segment: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Formulations |
|
|
64.1 |
|
|
|
65.5 |
|
|
|
68.1 |
|
|
|
11.8 |
|
|
|
8.3 |
|
Active pharmaceutical ingredients
and intermediates |
|
|
37.9 |
|
|
|
33.1 |
|
|
|
27.8 |
|
|
|
5.2 |
|
|
|
(23.6 |
) |
Generics |
|
|
75.2 |
|
|
|
69.5 |
|
|
|
54.7 |
|
|
|
(6.5 |
) |
|
|
(35.0 |
) |
Critical care and biotechnology |
|
|
45.3 |
|
|
|
49.6 |
|
|
|
66.5 |
|
|
|
5.3 |
|
|
|
71.8 |
|
Drug discovery |
|
|
|
|
|
|
|
|
|
|
100 |
|
|
|
|
|
|
[Nm] |
Other |
|
|
1.7 |
|
|
|
36.1 |
|
|
|
73.5 |
|
|
|
2556 |
|
|
|
222.9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total gross profit |
|
|
56.6 |
|
|
|
53.5 |
|
|
|
51.8 |
|
|
|
5.0 |
|
|
|
(6.0 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative
expenses |
|
|
28.2 |
|
|
|
32.7 |
|
|
|
35.0 |
|
|
|
28.6 |
|
|
|
3.8 |
|
Research and development expenses |
|
|
7.8 |
|
|
|
9.9 |
|
|
|
14.4 |
|
|
|
41.1 |
|
|
|
40.8 |
|
Amortization expenses |
|
|
2.4 |
|
|
|
1.9 |
|
|
|
1.8 |
|
|
|
(8.7 |
) |
|
|
(8.6 |
) |
Foreign exchange (gain)/loss |
|
|
0.4 |
|
|
|
(1.4 |
) |
|
|
2.5 |
|
|
[Nm] |
|
[Nm] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Operating Expenses |
|
|
38.8 |
|
|
|
43.1 |
|
|
|
53.7 |
|
|
|
23.6 |
|
|
|
20.8 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income |
|
|
17.8 |
|
|
|
10.4 |
|
|
|
(1.9 |
) |
|
|
(35.3 |
) |
|
Nm |
Equity in loss of affiliates |
|
|
(0.5 |
) |
|
|
(0.2 |
) |
|
|
(0.3 |
) |
|
|
(51.8 |
) |
|
|
31.0 |
|
Other (expense) / income, net |
|
|
3.8 |
|
|
|
2.6 |
|
|
|
2.7 |
|
|
|
(26.2 |
) |
|
|
5.4 |
|
Income before income taxes and minority interest |
|
|
21.1 |
|
|
|
12.6 |
|
|
|
0.5 |
|
|
|
(33.3 |
) |
|
|
(95.8 |
) |
Income tax benefit / (expenses) |
|
|
(2.2 |
) |
|
|
(0.3 |
) |
|
|
0.5 |
|
|
|
(82.6 |
) |
|
[Nm] |
Minority interest |
|
|
0.1 |
|
|
|
0.0 |
|
|
|
0.1 |
|
|
[Nm] |
|
|
195.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
|
18.8 |
|
|
|
12.3 |
|
|
|
1.1 |
|
|
|
(27.3 |
) |
|
|
(91.5 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal Year Ended March 31, 2005 Compared to Fiscal Year Ended March 31, 2004
Revenues
Total revenues decreased by 3.0% to Rs.19,471.9 million in fiscal 2005, as compared to
Rs.20,081.2 million in fiscal 2004, primarily due to a decrease in revenues in our generics and
active pharmaceutical ingredients and intermediates segments. In fiscal 2005, we received 22.3% of
our revenues from the United States and Canada, 34.4% from India, 14.3% from Russia and other
former Soviet Union countries, 14.7% from Europe and 14.3% from other countries.
Revenues from sales in Russia and other former Soviet Union countries increased by 21.7% to
Rs.2,782.2 million in fiscal 2005, as compared to Rs.2,285.8 million in fiscal 2004. The increase
was primarily due to an increase in sales of our major brands of formulations such as Nise, our
brand of nimesulide, Keterol, our brand of ketorolac tromethamine, and Omez, our brand of
omeprazole. Revenues from sales in Europe increased by 2.9% to Rs.2,868.2 million in fiscal 2005,
39
as compared to Rs.2,788.6 million in fiscal 2004, primarily as a result of an increase in
revenues from our generics segment largely offset by a decrease in revenues from our active
pharmaceutical ingredients and intermediates segment. Revenues from sales in North America
decreased by 18.2% to Rs.4,349.2 million in fiscal 2005, as compared to Rs.5,319.2 million in
fiscal 2004, primarily due to a decrease in revenues in our generics segment. Revenues from sales
in India decreased by 6.3% to Rs.6,693.0 million in fiscal 2005, as compared to Rs.7,143.4 million
in fiscal 2004, primarily due to a decrease in revenues in our formulations and
active
pharmaceutical ingredients and intermediates segments. We made allowances for sales returns of
Rs.105.2 million and Rs.169.5 million in fiscal 2005 and fiscal 2004, respectively.
Formulations. In fiscal 2005, we received 40.2% of our total revenues from the formulations
segment, as compared to 37.4% in fiscal 2004. Revenues in this segment increased by 4.2% to
Rs.7,822.9 million in fiscal 2005, as compared to Rs.7,507.5 million in fiscal 2004.
Revenues from sales in India constituted 55.7% of our total formulations revenues in fiscal
2005, as compared to 63.0% in fiscal 2004. Revenues from sales of formulations in India decreased
by 7.8% to Rs.4,360.2 million in fiscal 2005, as compared to Rs.4,729.4 million in fiscal 2004. New
products launched in India in fiscal 2005 accounted for 6% of the total revenues. These additional
revenues were more than offset by a decrease in revenues from sales of our key brands (such as
Omez, our brand of omeprazole, and Nise, our brand of nimesulide), as well as inventory reduction
by stockists, retailers and other trade channels in March 2005 due to uncertainty relating to the
implementation of the Value Added Tax (VAT) system in India.
Revenues from sales of formulations outside India increased by 24.6% to Rs.3,462.7 million in
fiscal 2005, as compared to Rs.2,778.1 million in fiscal 2004. Revenues from sales of formulations
in Russia accounted for 60.9% of our formulation revenues outside India in fiscal 2005, as compared
to 64.1% in fiscal 2004. Revenues from sales of formulations in Russia increased by 18.3% to
Rs.2,107.2 million in fiscal 2005, as compared to Rs.1,781.8 million in fiscal 2004. The increase
was driven by increased revenues from sales of our key brands such as Nise, our brand of
nimesulide, Ketorol, our brand of ketorolac tromethamine, Omez, our brand of omeprazole, and
Ciprolet, our brand of ciprofloxacin. Revenues from other former Soviet Union countries increased
by 31.2% to Rs.593.3 million for fiscal 2005, as compared to Rs.452.3 million for fiscal 2004,
primarily driven by an increase in revenues in Ukraine, Kazakhstan and Belarus. Revenues from the
rest of the world increased by 40.4% to Rs.613.1 million in fiscal 2005, as compared to Rs.436.6
million in fiscal 2004. This increase was primarily due to higher revenues from sales in South
Africa, Venezuela and new markets such as United Arab Emirates.
Active Pharmaceutical Ingredients and Intermediates. In fiscal 2005, we received 35.7% of our
total revenues from this segment, as compared to 38.0% in fiscal 2004. Revenues in this segment
decreased by 9.0% to Rs.6,944.5 million in fiscal 2005, as compared to Rs.7,628.5 million in fiscal
2004.
During fiscal 2005, revenues from sales in India accounted for 28.4% of our revenues from this
segment, as compared to 27.7% in fiscal 2004. Revenues from sales in India decreased by 6.8% to
Rs.1,972.1 million in fiscal 2005, as compared to Rs.2,115.1 million in fiscal 2004. This decrease
was primarily due to a decrease in sales volumes of ciprofloxacin, sparfloxacin and gatifloxacin.
Revenues from sales outside India decreased by 9.8% to Rs.4,972.4 million in fiscal 2005, as
compared to Rs.5,513.4 million in fiscal 2004. Revenues from sales in Europe decreased by 32.9% to
Rs.1,091.2 million in fiscal 2005, as compared to Rs.1,626.9 million in fiscal 2004 primarily due
to a decrease in revenues from ramipril. Ramipril, launched in Europe in fiscal 2004, accounted for
Rs.753.3 million in revenue in fiscal 2005 compared to Rs.1,237.5 million in fiscal 2004. This
decline was primarily due to a reduction in price due to additional competition. Revenues from
sales in the United States and Canada decreased by 2.8% to Rs.1,849.0 million in fiscal 2005, as
compared to Rs.1,902.9 million in fiscal 2004, primarily due to additional competition for our
existing products.
Generics. In fiscal 2005, we received 18.4% of our total revenues from this segment, as
compared to 21.6% in fiscal 2004. Revenues decreased by 17.5% to Rs.3,577.4 million in fiscal 2005,
as compared to Rs.4,337.5 million in fiscal 2004. Revenues from sales in the United States and
Canada decreased by 34.4% to Rs.2,230.1 million in fiscal 2005, as compared to Rs.3,398.6 million
in fiscal 2004. This was primarily on account of increased competition with respect to sales of
tizanidine and fluoxetine. Together these two products accounted for Rs.1,134.7 million in revenue
in fiscal 2005 as compared to Rs.2,402.8 million in fiscal 2004. This decline was partially offset
by revenues from new product launches of ciprofloxacin (launched in June 2004) and citalopram
(launched in October 2004). Revenues in Europe increased by 44.1%
40
to Rs.1,339.6 million in fiscal 2005, as compared to Rs.929.9 million in fiscal 2004,
primarily due to growth in sales volumes of omeprazole and amlodipine maleate (launched in March
2004).
Critical Care and Biotechnology. We received 2.7% of our total revenues from this segment in
fiscal 2005, as compared to 2.0% in fiscal 2004. Revenues in this segment increased to Rs.527.1
million in fiscal 2005, as compared to Rs.411.0 million in fiscal 2004.
Revenues from our critical care division increased by Rs.82.7 million, primarily due to an
increase in domestic revenues from sales of key products of Dacotin, our brand of oxaliplatin,
Docetere, our brand of docetaxel, and Mitotax, our brand of paclitaxel. Revenues from our
biotechnology division increased by Rs.42.6 million, primarily due to sales volume growth of
Grastim, our brand of filgrastim.
Drug Discovery. Revenues from our drug discovery segment were at Rs.288.4 million for fiscal
2005, as compared to no revenue for fiscal 2004. In September 2001, we received Rs.235.6 million as
an upfront license fee from Novartis Pharma A.G. in connection with our out-licensing of DRF 4158
to Novartis. During fiscal 2005, on expiration of the terms of the agreement with Novartis, we
accounted for the upfront license fee as income, which was deferred in the year ended March 31,
2002 as the up-front license fee did not represent the culmination of a separate earning process,
the up-front license fee had been deferred to be recognized in accordance with our accounting
policy proportionately upon the receipt of stated milestones. During fiscal 2005, we recognized an
amount of Rs.52.8 million towards DRF 2593 pursuant to the discontinuation of our agreement with
Novo Nordisk.
Others. Revenues from our Custom Pharmaceutical Services segment were Rs.311.6 million in
fiscal 2005, as compared to Rs.113.1 million in fiscal 2004. The increase is primarily on account
of increases in both our customer base and our product portfolio.
Cost of revenues
Total cost of revenues increased by Rs.39.7 million to Rs.9,385.8 million for fiscal 2005, as
compared to Rs.9,346.1 million for fiscal 2004. Cost of revenues as a percentage of total revenues
was 48.2% for fiscal 2005, as compared to 46.5% for fiscal 2004.
Formulations. Cost of revenues in this segment decreased by 3.6% to Rs.2,492.8 million in
fiscal 2005, as compared to Rs.2,586.5 million in fiscal 2004. Cost of revenues in this segment
was 31.9% of formulations revenues for fiscal 2005, as compared to 34.5% of formulations revenues
for fiscal 2004. The decrease in cost of revenues as a percentage of revenues was primarily due to
a higher proportion of revenues from outside India, which generate relatively higher gross margins.
Active Pharmaceutical Ingredients and Intermediates. Cost of revenues in this segment
decreased by 1.7% to Rs.5,013.6 million in fiscal 2005, as compared to Rs.5,102.4 million in fiscal
2004. Cost of revenues in this segment has increased to 72.2% of this segments revenues in fiscal
2005, as compared to 66.9% of the segments revenues in fiscal 2004. The increase in cost of
revenues as a percentage of sales was primarily due to a decrease in revenues from sales of
ramipril in Europe, which generates a higher gross margin compared to the segments average gross
margin, as well as a higher proportion of revenues from India, which generate lower gross margins,
all as compared to fiscal 2004.
Generics. Cost of revenues in this segment increased by 22.3% to Rs.1,620.4 million in fiscal
2005, as compared to Rs.1,324.5 million in fiscal 2004. Cost of revenues was 45.3% of this
segments revenues in fiscal 2005, as compared to 30.5% in fiscal 2004. The cost of revenues as a
percentage of revenues increased primarily due to a decline in revenues from sales of our key
products fluoxetine and tizanidine, which generate a higher gross margin compared to segments
average gross margins.
Critical Care and Biotechnology. Cost of revenues in this segment decreased by 14.7% to
Rs.176.5 million in fiscal 2005, as compared to Rs.207.0 million in fiscal 2004. Cost of revenues
in this segment decreased to 33.5% of this segments revenues in fiscal 2005, as compared to 50.4%
in fiscal 2004. The decrease in cost of revenues is primarily due to a decrease in input costs of
certain existing products.
41
Gross profit and gross margin
As a result of the trends described in Revenues and Cost of revenues above, our gross
profit decreased by 6.0% to Rs.10,086.1 million for fiscal 2005 from Rs.10,735.1 million during
fiscal 2004. Gross margin was 51.8% in fiscal 2005, as compared to 53.5% in fiscal 2004.
The gross margin for our formulations segment increased to 68.1% in fiscal 2005, as compared
to 65.5% in fiscal 2004. The gross margin for our active pharmaceutical ingredients segment
decreased to 27.8% in fiscal 2005, as compared to 33.1% in fiscal 2004. The gross margin for our
generics segment decreased to 54.7% in fiscal 2005, as compared to 69.5% in fiscal 2004. The gross
margin for our critical care and biotechnology segment was 66.5% in fiscal 2005, as compared to
49.6% in fiscal 2004.
Selling, general and administrative expenses
Selling, general and administrative expenses increased by 3.8% to Rs.6,810.4 million in fiscal
2005, as compared to Rs.6,562.9 million in fiscal 2004. Selling, general and administrative
expenditures as a percentage of total revenues were 35.0% for fiscal 2005 as compared to 32.7% for
fiscal 2004. This increase is largely due to an increase in employee costs, which was largely
offset by a decrease in legal and professional expenses. Employee costs increased by 21.5% to
Rs.2,062.5 million in fiscal 2005, as compared to Rs.1,697.0 million in fiscal 2004, primarily due
to annual salary increases and market corrections as well as an increase in the number of employees
in our international offices. Legal and professional expenses decreased by 24.1% to Rs.995.0
million in fiscal 2005, as compared to Rs.1,311.0 million in fiscal 2004, primarily due to lower
legal and consultancy activity during fiscal 2005.
Research and development expenses
Research and development costs increased by 40.8% to Rs.2,803.3 million for fiscal 2005, as
compared to Rs.1,991.6 million for fiscal 2004. As a percentage of revenue, research and
development expenditure accounted for 14.4% of total revenue in fiscal 2005, as compared to 9.9% in
fiscal 2004. The increase was primarily on account of a charge of Rs.277.0 million recorded
against research and development in-process associated with our acquisition of Trigenesis
Therapeutics, Inc., international clinical trials in our drug discovery segment and an increase in
research and development activity in our active pharmaceutical ingredients and intermediates,
formulations, generics and biotechnology businesses. During the year, we entered into a research
and development partnership agreement with I-VEN Pharma Capital Limited (I-VEN) for the
development and commercialization of ANDAs to be filed in the U.S. in 2004-05 and 2005-06. Under
the terms of the agreement, we received U.S.$22.5 million in March 2005 of which U.S.$2.2 million
was recorded as a reduction in research and development expense in fiscal 2005.
Amortization expenses
Amortization expenses decreased by 8.6% to Rs.350.0 million in fiscal 2005, as compared to
Rs.382.9 million in fiscal 2004. The decrease was primarily on account of higher amortization of
our acquired brands and other intangibles in fiscal 2004.
Foreign exchange gain/loss
Foreign exchange loss was Rs.488.8 million for fiscal 2005 as compared to a gain of Rs.282.4
million for fiscal 2004. The loss was mainly on account of losses resulting from marking to market
of our forward derivative contracts partially offset by gains realized on maturity of these forward
derivative contracts.
Operating income
As a result of the foregoing, our operating loss was at Rs.366.5 million in fiscal 2005, as
compared to an operating gain of Rs.2,080.0 million in fiscal 2004. Operating loss as a percentage
of total revenues was 1.9% in fiscal 2005, as compared to 10.4% in fiscal 2004.
42
Other (expense)/income, net
For fiscal 2005 our other income was Rs.531.6 million, as compared to Rs.504.2 million for
fiscal 2004. This includes net interest income of Rs.272 million in fiscal 2005 as compared to
Rs.406.8 million in fiscal 2004. This decrease in net interest income was partially offset by an
increase in income from sale of investments by Rs.90.4 million. There was also a loss resulting
from the sale of fixed assets in Pondicherry, India in our formulations business and certain other
assets during fiscal 2004. No such loss was recorded in fiscal 2005.
Equity in loss of affiliates
Equity in loss of affiliates increased by Rs.13.7 million to Rs.58.1 million for fiscal 2005
from Rs.44.4 million for fiscal 2004, primarily due to an increase in loss pick up in Kunshan Rotam
Reddy Pharmaceuticals, which is accounted under the equity investee method.
Income before income taxes and minority interest
As a result of the foregoing, income before income taxes and minority interest decreased by
95.8% to Rs.107.0 million in fiscal 2005, as compared to Rs.2,540.3 million in fiscal 2004. As a
percentage of revenues, income before income taxes and minority interest was 0.5% of revenues in
fiscal 2005, as compared to 12.6% of revenues in fiscal 2004.
Income tax expense
We recorded a net income tax credit of Rs.94.3 million for fiscal 2005, as compared to an
expense of Rs.69.2 million for fiscal 2004. The decrease was primarily on account of a decline in
overall profits; higher research and development expenditures, which are eligible for weighted tax
deductions partially offset by an increase in the enacted tax rate in India from 35.875% to
36.5925%.
Minority interest
Loss attributable to minority interest for fiscal 2005 was Rs.9.9 million, as compared to
Rs.3.4 million for fiscal 2004. This represents the minority interest in the losses of Dr. Reddys
Laboratories (Proprietary) Limited, our 60% subsidiary in South Africa.
Net income
As a result of the above, our net income decreased by 91.5% to Rs.211.2 million in fiscal
2005, as compared to Rs.2,474.4 million in fiscal 2004. Net income as a percentage of total
revenues decreased to 1.1% in fiscal 2005 from 12.3% in fiscal 2004.
Fiscal Year Ended March 31, 2004 Compared to Fiscal Year Ended March 31, 2003
Revenues
Total revenues increased by 11.1% to Rs.20,081.2 million in fiscal 2004, as compared to
Rs.18,069.8 million in fiscal 2003, primarily due to an increase in revenues in our active
pharmaceutical ingredients and intermediates and formulations segments. In fiscal 2004, we received
26.5% of our revenues from the United States and Canada, 35.6% of our revenues from India, 11.4% of
our revenues from Russia and other former Soviet Union countries, 13.9% of our revenues from Europe
and 12.6% of our revenues from other countries.
Sales to Russia and other former Soviet Union countries increased by 8.4% to Rs.2,285.8
million in fiscal 2004, as compared to Rs.2,107.9 million in fiscal 2003. The increase was
primarily driven by formulations revenues, particularly with respect to the major brands Nise, our
brand of nimesulide, Keterol, our brand of ketorolac tromethamine, and Omez, our brand of
omeprazole. Sales to Europe increased by 99.0% to Rs.2,788.6 million in fiscal 2004, as compared to
Rs.1,401.0 million in fiscal 2003, primarily as a result of the commencement of sales of ramipril
in our active pharmaceutical ingredients and intermediates segment. Sales in India increased by
10.1% to Rs.7,143.8 million in fiscal 2004, as compared to Rs.6,488.6 million in fiscal 2003,
primarily due to an increase in revenues in our formulations and
43
active pharmaceutical ingredients and intermediates segments. Sales to North America decreased
by 9.1% to Rs.5,319.2 million in fiscal 2004, as compared to Rs.5,852.6 million in fiscal 2003,
primarily due to a decrease in revenues in our active pharmaceutical ingredients and intermediates
segment and generics segment. We made allowances for sales returns of Rs.169.5 million and Rs.193.2
million in fiscal 2004 and fiscal 2003, respectively.
Formulations. In fiscal 2004, we received 37.4% of our total revenues from the formulations
segment, as compared to 38.0% in fiscal 2003. Revenues in this segment increased by 9.4% to
Rs.7,507.5 million in fiscal 2004, as compared to Rs.6,860.4 million in fiscal 2003.
Sales in India constituted 63.0% of our total formulations sales in fiscal 2004, as compared
to 62.7% in fiscal 2003. Sales of formulations in India increased by 9.9% to Rs.4,729.4 million in
fiscal 2004, as compared to Rs.4,303.2 million in fiscal 2003. The overall increase in sales was
primarily due to an increase in sales of our key brands Omez, our brand of omeprazole, Nise, our
brand of nimesulide, Stamlo Beta, our brand of amlodipine and atenolol, Stamlo our brand of
amlodipine, and Enam our brand of enalapril maleate.
Sales of formulations outside India increased by 8.6% to Rs.2,778.1 million in fiscal 2004, as
compared to Rs.2,557.2 million in fiscal 2003. Sales of formulations in Russia accounted for 64.1%
of our formulation sales outside India in fiscal 2004, as compared to 65.0% in fiscal 2003. Sales
of formulations in Russia increased by 7.2% to Rs.1,781.8 million in fiscal 2004, as compared to
Rs.1,661.9 million in fiscal 2003. The increase was driven by key brands such as Nise, our brand of
nimesulide, Ketorol, our brand of ketorolac tromethamine, and Omez, our brand of omeprazole. Sales
to other former Soviet Union countries increased by 5.1% to Rs.452.3 million for fiscal 2004 as
compared to Rs.430.4 million for fiscal 2003, primarily driven by an increase in sales in Ukraine
and Kazakhstan, which increase has been partially offset by decrease in sales in Belarus,
Uzbekistan and Kyrgyzstan.
Active Pharmaceutical Ingredients and Intermediates. In fiscal 2004, we received 38.0% of our
total revenues from this segment as compared to 35.1% in fiscal 2003. Revenues in this segment
increased by 20.3% to Rs.7,628.5 million in fiscal 2004, as compared to Rs.6,340.7 million in
fiscal 2003.
During fiscal 2004, sales in India accounted for 27.7% of our revenues from this segment, as
compared to 27.6% in fiscal 2003. Sales in India increased by 20.9% to Rs.2,115.1 million in fiscal
2004, as compared to Rs.1,749.1 million in fiscal 2003. This increase was primarily due to an
increase in sales volumes of ciprofloxacin, atorvastatin, norfloxacin, losartan potassium,
ibuprofen and ranitidine hydrochloride.
Sales outside India increased by 20.1% to Rs.5,513.4 million in fiscal 2004, as compared to
Rs.4,591.6 million in fiscal 2003. Sales in Europe increased by 249.1% to Rs.1,626.9 million in
fiscal 2004, as compared to Rs.466.0 million in fiscal 2003 primarily due to our launch of
ramipril, which contributed Rs.1,238.0 million in revenue. Sales in North America decreased by
20.6% to Rs.1,902.9 million in fiscal 2004, as compared to Rs.2,397.7 million in fiscal 2003,
primarily due to a decrease in sales of nizatidine by Rs.480.5 million. This decline was primarily
on account of a decline in sales volumes.
Generics. In fiscal 2004, we received 21.6% of our total revenues from this segment, as
compared to 23.7% in fiscal 2003. Revenues increased by 1.2% to Rs.4,337.5 million in fiscal 2004,
as compared to Rs.4,284.2 million in fiscal 2003. Sales in North America decreased by 1.3% to
Rs.3,398.6 million in fiscal 2004, as compared to Rs.3,444.9 million in fiscal 2003. This was
primarily on account of increased competition for tizanidine and fluoxetine. Together, these
products contributed Rs.2,402.8 million in revenue in fiscal 2004 compared to Rs.2,567.1 million in
fiscal 2003. This decline was partially offset by the contribution from sales of new products such
as ibuprofen (sales commenced in January 2003) and nefazodone (sales commenced in September 2003).
Sales in Europe increased by 14.3% to Rs.929.9 million in fiscal 2004, as compared to Rs.813.9
million in fiscal 2003, primarily due to an increase in revenues from omeprazole capsules. This
revenue increase was due to an increase in sales volumes for that product, which was partially
offset by a reduction in its price. We commenced sales of amlodipine maleate in the U.K. in March
2004, and recorded revenues of Rs.17.7 million in fiscal 2004 for this product.
Diagnostics, Critical Care and Biotechnology. We received 2.0% of our total revenues from this
segment in fiscal 2004 as compared to 2.4% in fiscal 2003. Revenues in this segment decreased to
Rs.411.0 million in fiscal 2004, as compared to Rs.428.2 million in fiscal 2003.
Revenues in this segment decreased primarily due to a decrease in revenues from our
diagnostics division to Rs.9.1 million for fiscal 2004, as compared to Rs.136.8 million for fiscal
2003, due to discontinuation of the trading operations of
44
the diagnostics division in fiscal 2004. This decrease was partially offset by an increase in
sales from our critical care division by Rs.89.7 million, primarily on account of an increase in
exports. The increase in exports was primarily due to increases in sales volumes of Docetere (20 mg
and 80 mg) and Mitotax (30 mg, 100 mg and 250 mg) and commencement of the sales of our oncology
products in Brazil. The decrease in revenue in this division was also partially offset by an
increase in revenues of the biotechnology division by Rs.20.8 million, primarily due to an increase
in sales volumes of Grastim, our brand of filgrastim.
Others. Revenues from drug discovery and our other businesses constituted an insignificant
portion of our total revenues for fiscal 2004 and fiscal 2003.
Cost of revenues
Cost of revenues increased by 19.1% to Rs.9,346.1 million for fiscal 2004, as compared to
Rs.7,847.6 million for fiscal 2003. Cost of revenues as a percentage of total revenues was 46.5%
for fiscal 2004, as compared to 43.4% for fiscal 2003.
Formulations. Cost of revenues in this segment was 34.5% of formulations revenues for fiscal
2004, as compared to 35.9% of formulations revenues for fiscal 2003. In absolute terms, cost of
revenues increased by 5.1% to Rs.2,586.5 million in fiscal 2004, as compared to Rs.2,460.2 million
in fiscal 2003. The decrease in cost of revenues as a percentage of sales was primarily
attributable to a decrease in the cost of raw materials and a decrease in excise duty expenses. The
decrease in excise duty expenses was due to a change in the method used to calculate the excise
duties owed for products manufactured at third party manufacturing locations and product samples
manufactured at our own plants. We changed from the selling price method of calculation of excise
duties to the cost construction method, which is based upon the cost to us of materials and
conversion to finished product. This change in calculation method was permitted as a result of a
notice issued by the Indian Central Excise Authorities.
Active Pharmaceutical Ingredients and Intermediates. Cost of revenues in this segment has
increased to 66.9% of this segments revenues in fiscal 2004, as compared to 62.1% of the segments
revenues in fiscal 2003. In absolute terms, cost of revenues increased by 29.5% to Rs.5,102.4
million in fiscal 2004, as compared to Rs.3,938.7 million in fiscal 2003. The increase was
primarily due to a decrease in sales to North America, on which we earn a higher margin as compared
to the average gross margin of this segment.
Generics. Cost of revenues was 30.5% of this segments revenues in fiscal 2004, as compared to
24.8% in fiscal 2003. In absolute terms, cost of revenues increased by 24.9% to Rs.1,324.5 million
in fiscal 2004, as compared to Rs.1,060.7 million in fiscal 2003. The cost of revenues as a
percentage of sales increased, primarily due to reduced sales of fluoxetine and omeprazole, on
which we earn a higher margin as compared to the average gross margin of this segment.
Diagnostics, Critical Care and Biotechnology. Cost of revenues in this segment decreased to
50.4% of this segments revenues in fiscal 2004, as compared to 54.7% in fiscal 2003. Cost of
revenues decreased by 11.7% to Rs.207.0 million in fiscal 2004, as compared to Rs.234.4 million in
fiscal 2003, primarily on account of discontinuation of trading operations of the diagnostics
division and, to a lesser extent, a decrease in excise duties. This decrease in cost of revenues
was partially offset by an increase in material consumption at our critical care and biotechnology
divisions. The decrease in excise duties was primarily due to a change in central excise rules
whereby the duties on four products (Irnotecan, Pamired, Cytogem and Grastim) were eliminated.
Gross profit
As a result of the factors described in Revenues and Cost of revenues above, our gross
profit increased by 5.0% to Rs.10,735.1 million for fiscal 2004, as compared to Rs.10,222.2 million
for fiscal 2003. Gross margin was 53.5% in fiscal 2004, as compared to 56.6% in fiscal 2003.
Gross margin of the formulations segment increased to 65.5% in fiscal 2004, as compared to
64.1% in fiscal 2003. The gross margin for our active pharmaceutical ingredients segment decreased
to 33.1% in fiscal 2004, as compared to 37.9% in fiscal 2003. The gross margin for our generics
segment decreased to 69.5% in fiscal 2004, as compared to 75.2% in fiscal 2003. The gross margin
for our diagnostics, critical care and biotechnology segment was 49.6% in fiscal 2004, as compared
to 45.3% in fiscal 2003.
Selling, general and administrative expenses
45
Selling, general and administrative expenditures as a percentage of total revenues were 32.7%
for fiscal 2004 as compared to 28.2% for fiscal 2003. Selling, general and administrative expenses
increased by 28.6% to Rs.6,562.9 million in fiscal 2004, as compared to Rs.5,103.2 million in
fiscal 2003. This increase was largely due to an increase in legal and consultancy expenses,
insurance expenses, marketing expenses and employee costs. Legal and consultancy expenditures
increased by Rs.357.4 million, primarily on account of expenses relating to various patent
challenges as well as regulatory submissions coupled with consultancy expenses related to the
amlodipine maleate product. These consultancy expenses were incurred as we were preparing to
commence sales of amlodipine maleate as the initial product for our specialty products business in
the U.S. Insurance expenditure increased by Rs.131.0 million primarily due to higher product
liability insurance costs. Selling and marketing expenses increased by 30.6% to Rs.2,316.1 million
for fiscal 2004 from Rs.1,806.4 million for fiscal 2003 due to an increase in carriage outwards
(i.e., transportation) expenses, marketing expenses incurred for the amlodipine maleate product and
a provision of Rs.183.6 million related to our dispute regarding the application of Indian price
controls to our norfloxacin product). Employee costs have increased by 25.5% to Rs.1,699.6 million
in fiscal 2004, as compared to Rs.1,353.9 million in fiscal 2003. This increase in employee costs
was primarily due to an increase in the number of employees, including key recruitments at senior
levels, and an increase in compensation costs attributable to market factors.
Research and development expenses
Research and development expenditures increased by 41.1% to Rs.1,991.6 million for fiscal
2004, as compared to Rs.1,411.8 million for fiscal 2003. As a percentage of revenue, research and
development expenditure is at 9.9% of total revenue in fiscal 2004 as compared to 7.8% in fiscal
2003. The increase was primarily on account of an increase in expenses incurred in the generics
segment (including the specialty area) relating to product development and bio-studies. We invested
Rs.729.3 million in drug discovery in fiscal 2004 as compared to Rs.480.1 million in fiscal 2003.
This increase was primarily on account of an increase in expenditures on clinical trials in drug
discovery and an increase in employee costs.
Amortization expenses
Amortization expenses decreased by 8.7% to Rs.382.9 million in fiscal 2004, as compared to
Rs.419.4 million in fiscal 2003. The decrease was primarily on account of higher amortization of
our acquired dental brands in India and other intangibles in fiscal 2003.
Foreign exchange gain/loss
Foreign exchange gain was Rs.282.4 million for fiscal 2004 as compared to a loss of Rs.70.1
million for fiscal 2003. The gain was mainly due to gains from marking to market of our forward
derivative contracts and gains realized on maturity of these forward derivative contracts,
partially offset by losses due to exchange rate factors.
46
Operating income
As a result of the foregoing, our operating income decreased by 35.3% to Rs.2,080.2 million in
fiscal 2004, as compared to Rs.3,217.6 million in fiscal 2003. Operating income as a percentage of
total revenues was 10.4% in fiscal 2004, as compared to 17.8% in fiscal 2003.
Other income, net
For fiscal 2004 our other income was Rs.504.2 million, as compared to Rs.683.1 million for
fiscal 2003. Interest income increased by 23.1% to Rs.421.8 million in fiscal 2004, as compared to
Rs.342.5 million in fiscal 2003. This increase is on account of an increase in interest income on
fixed deposits and debentures of Rs.79.2 million. This increase in interest income was partially
offset by a loss of Rs.58.4 million recognized upon our sale of 51% of the equity of Compact
Electric Limited, which was previously a wholly owned subsidiary and is now only 49% owned by us.
Equity in loss of affiliates
Equity in loss of affiliates decreased by Rs.47.7 million to Rs.44.4 million for fiscal 2004
from Rs.92.1 million for fiscal 2003. This decrease was primarily due to a decrease in loss pick up
in Kunshan Rotam Reddy Pharmaceuticals, our joint venture in China, and the absence of a loss
pickup in Pathnet India Pvt. Limited, our equity investee in India, as occurred in fiscal 2003. The
entire investment in Pathnet was written down to zero in fiscal 2003.
Income before income taxes and minority interest
As a result of the foregoing, income before income taxes and minority interest decreased by
33.3% to Rs.2,540.0 million in fiscal 2004, as compared to Rs.3,808.6 million in fiscal 2003. As a
percentage of revenues, income before income taxes and minority interest was 12.6% of revenues in
fiscal 2004, as compared to 21.1% of revenues in fiscal 2003.
Income tax expense
We recorded an income tax expense of Rs.69.2 million for fiscal 2004, as compared to Rs.398.0
million for fiscal 2003. Our effective tax rate has decreased to 2.7% for fiscal 2004 from 10.5%
for fiscal 2003. This decrease was primarily on account of an increase in profits from units set up
in backward areas, which have tax concessions; higher research and development expenditures, which
are eligible for weighted tax deductions; and reduction of enacted tax rate in India from 36.75% to
35.875%. However the decreased income tax expense was partly offset by a reduction in tax
concessions related to export earnings.
Minority interest
Loss attributable to minority interest for fiscal 2004 was Rs.3.4 million as compared to
profit attributable to minority interest of Rs.6.7 million for fiscal 2003. In fiscal 2004, there
was no minority interest attributable to OOO JV Reddy Biomed Limited, which is now a 100%
subsidiary as a result of our acquisition of the remaining equity interests in fiscal 2003. In
fiscal 2004, the minority interest represented a minority interest in the losses of Dr. Reddys
Laboratories (Proprietary) Limited, our 60% subsidiary in South Africa.
Net income
As a result of the above, our net income decreased by 27.3% to Rs.2,474.2 million in fiscal
2004, as compared to Rs.3,403.9 million in fiscal 2003. Net income as a percentage of total
revenues decreased to 12.3% in fiscal 2004 from 18.8% in fiscal 2003.
Recent Accounting Pronouncements
In November 2004, the Financial Accounting Standards Board (FASB) issued Statement of
Financial Accounting Standards (SFAS) No. 151, Amendment of Accounting Research Bulletin (ARB)
No. 43, Chapter 4 on Inventory Costs. SFAS 151 amends and clarifies financial accounting and
reporting for inventory costs. SFAS 151 is effective for inventory costs incurred during fiscal
years beginning after June 15, 2005. We are evaluating the impact of adoption of SFAS 151 on our
consolidated financial statements.
47
In December 2004, the FASB issued SFAS No. 123R (revised 2004), Share-Based Payment (SFAS
123R). SFAS 123R is an amendment of FASB statement No. 123, Accounting for Stock-Based
Compensation. This statement also supersedes Accounting Principles Board (APB) Opinion No. 25,
Accounting for Stock Issued to Employees. SFAS 123R focuses primarily on accounting for
transactions in which an entity obtains employee services in share-based payment transactions.
Pursuant to the Securities and Exchange Commission Release No. 33-8568, we are required to adopt
SFAS 123R effective as of April 1, 2006. Adoption of SFAS 123R will not have any material impact
on our consolidated financial statements, as we have already adopted fair value accounting under
SFAS 123.
Critical Accounting Policies
Critical accounting policies are those most important to the portrayal of our financial
condition and results and that require the most exercise of our judgment. We consider the policies
discussed under the following paragraphs to be critical for an understanding of our financial
statements. Our significant accounting policies and application of these are discussed in detail in
Note 2 to the Consolidated Financial Statements.
Accounting Estimates
While preparing financial statements we make estimates and assumptions that affect the
reported amount of assets, liabilities, disclosure of contingent liabilities at the balance sheet
date and the reported amount of revenues and expenses for the reporting period. Financial reporting
results rely on our estimate of the effect of certain matters that are inherently uncertain. Future
events rarely develop exactly as forecast and the best estimates require adjustments, as actual
results may differ from these estimates under different assumptions or conditions. We continually
evaluate these estimates and assumptions based on the most recently available information.
Specifically, we make estimates of:
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the useful life of property, plant and equipment; |
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impairment of long-lived assets, including identifiable intangibles and goodwill; |
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our future obligations under employee retirement and benefit plans; |
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allowances for sales returns; |
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allowances for doubtful accounts receivable; and |
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inventory write-downs. |
We depreciate property, plant and equipment over their useful lives using the straight-line
method. Estimates of useful life are subject to changes in economic environment and different
assumptions. Assets under capital leases are amortized over their estimated useful life or lease
term as appropriate. We review long-lived assets, including identifiable intangibles and goodwill,
for impairment whenever events or changes in circumstances indicate that the carrying amount of an
asset may not be recoverable. We measure recoverability of assets to be held and used by comparing
the carrying amount of an asset to future net undiscounted cash flows expected to be generated by
the asset. If such assets are considered to be impaired, the impairment to be recognized is
measured by the amount by which the carrying amount of the assets exceeds the fair value of the
assets. Considerable management judgment is necessary to estimate discounted future cash flows.
Accordingly, actual outcomes could vary significantly from such estimates. Factors such as changes
in the planned use of buildings, machinery or equipment or lower than anticipated sales for
products with capitalized rights could result in shortened useful lives or impairment.
In accordance with applicable Indian laws, we provide a defined benefit retirement plan
(Gratuity Plan) covering certain categories of employees. The Gratuity Plan provides a lump sum
payment to vested employees at retirement or termination of employment, in an amount based on the
respective employees last drawn salary and the years of employment with us. Liabilities with
regard to the Gratuity Plan are determined by an actuarial valuation, based upon which we make
contributions to the Gratuity Fund. In calculating the expense and liability related to the plans,
assumptions are made about the discount rate, expected rate of return on plan assets, withdrawal
and mortality rates and rate of future compensation increases as determined by us, within certain
guidelines. The assumptions used may differ materially from actual results, resulting in a probable
significant impact to the amount of expense recorded by us.
48
Allowances for sales returns are estimated and provided for in the year of sales. Such
allowances are made based on our historical trends. We have the ability to make a reasonable
estimate of the amount of future returns due to our large volume of homogeneous transactions and
historical experience with similar types of sales of products. In respect of new products for which
sales have commenced or are expected to commence, the sales returns are not expected to be
different from the existing products as such products relate to the therapeutic categories where
established products exist and are sold in the market. Further, we evaluate the sales returns of
all products at the end of each reporting period and necessary adjustments, if any, are made.
However, no significant revisions have been determined to be necessary to date.
We make allowance for doubtful accounts receivable, including receivables sold with recourse,
based on the present and prospective financial condition of the customer and ageing of the accounts
receivable after considering historical experience and the current economic environment. Actual
losses due to doubtful accounts may differ from the allowances made. However, we believe that such
losses will not materially affect our consolidated results of operations.
We provide for inventory obsolescence, expired inventory and inventories with carrying values
in excess of realizable values based on our assessment of future demands, market conditions and our
specific inventory management initiatives. If the market conditions and actual demands are less
favorable than our estimates, additional inventory write-downs may be required. In all cases,
inventory is carried at the lower of historical costs or realizable value.
Revenue Recognition
Product sales: Revenue is recognized when significant risks and rewards in respect of
ownership of products are transferred to the customer, generally, the stockists or the formulations
manufacturers, and when the following criteria are met:
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Persuasive evidence of an arrangement exists; |
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The price to the buyer is fixed and determinable; and |
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Collectibility of the sales price is reasonably assured. |
Revenue from domestic sales of formulation products is recognized on dispatch of the product
to the stockist by our consignment and clearing and forwarding agent. Revenue from domestic sales
of active pharmaceutical ingredients and intermediates is recognized on dispatch of products to
customers from our factories. Revenue from export sales is recognized when significant risks and
rewards are transferred to the customer, generally upon shipment of products.
Revenue from product sales includes excise duties and is shown net of sales tax and applicable
discounts and allowances.
Sales of formulations in India are made through clearing and forwarding agents to stockists.
Significant risks and rewards in respect of ownership of formulation products is transferred by us
when the goods are shipped to stockists from clearing and forwarding agents. Clearing and
forwarding agents are generally compensated on a commission basis as a percentage of sales made by
them.
Sales of active pharmaceutical ingredients and intermediates in India are made directly to the
end customers, generally formulation manufacturers, from the factories. Sales of formulations and
active pharmaceutical ingredients and intermediates outside India are made directly to the end
customers, generally stockists or formulations manufacturers, from us or our consolidated
subsidiaries.
We have entered into marketing arrangements with certain marketing partners for the sale of
goods. Under such arrangements, we sell generic products to the marketing partners at a price
agreed in the arrangement. Revenue is recognized on these transactions upon delivery of products
to the marketing partners as all the conditions under Staff Accounting Bulletin No.104 (SAB 104)
are then met. Subsequently, the marketing partners remit an additional amount upon further sales
made by them to the end customer. Such amount is determined as per the terms of the arrangement
and is recognized by us when the realization is certain under the guidance given in SAB 104.
We have entered into certain dossier sales, licensing and supply arrangements that include
certain performance obligations. Based on an evaluation of whether or not these obligations are
inconsequential or perfunctory, we defer the upfront payments received towards these arrangements.
Such deferred amounts are recognized in the income statement in the period in which we complete our
remaining performance obligations. Allowances for sales returns are estimated and provided for in
the year of sales. Such allowances are made based on historical trends. We have the ability to
make a
49
reasonable estimate of the amount of future returns due to large volumes of homogeneous
transactions and historical experience with similar types of sales of products. In respect of new
products for which sales have commenced or are expected to commence, the sales returns are not
expected to be different from the existing products as such products relate to the therapeutic
categories where established products exist and are sold in the market. Further, we evaluate the
sales returns of all the products at the end of each reporting period and necessary adjustments, if
any, are made. However, no significant revisions have been determined to be necessary to date.
License fees: Non-refundable milestone payments are recognized in the statement of income when
earned, in accordance with the terms prescribed in the license agreement, and where we have no
future obligations or continuing involvement pursuant to such milestone payment. Non-refundable
up-front license fees are deferred and recognized when the milestones are earned, in proportion
that the amount of each milestone earned bears to the total milestone amounts agreed in the license
agreement. As the upfront license fees are a composite amount and cannot be attributed to a
specific molecule, they are amortized over the development period. The milestone payments during
the development period increase as the risk involved decreases. The agreed milestone payments
reflect the progress of the development of the molecule and may not be spread evenly over the
development period. Further, the milestone payments are a fair representation of the extent of
progress made in the development of these molecules. Hence, the upfront license fees are amortized
over the development period in proportion to the milestone payments received. In the event the
development is discontinued, the corresponding amount of deferred revenue is recognized in the
income statement in the period in which the project is effectively terminated.
Stock Based Compensation
We use the Black-Scholes option pricing model to determine the fair value of each option
grant. The Black-Scholes model includes assumptions regarding dividend yields, expected volatility,
expected lives and risk free interest rates. These assumptions reflect our best estimates, but
these assumptions involve inherent market uncertainties based on market conditions generally
outside of our control. As a result, if other assumptions had been used in the current period,
stock-based compensation expense could have been materially impacted. Furthermore, if we use
different assumptions in future periods, stock based compensation expense could be materially
impacted in future years.
The fair value of each option is estimated on the date of grant using the Black-Scholes model
with the following assumptions:
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Fiscal
Year Ended March 31, |
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2003 |
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2004 |
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2005 |
Dividend yield |
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0.4 |
% |
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0.5 |
% |
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0.5 |
% |
Expected life |
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42-78 months |
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42-78 months |
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12-78 months |
Risk free interest rates |
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5.8-6.8 |
% |
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5.2-6.8 |
% |
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4.5-6.7 |
% |
Volatility |
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49.8-50.7 |
% |
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45.7-50.7 |
% |
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39.4-44.6 |
% |
At March 31, 2005, we had three stock-based employee compensation plans, which are described
more fully in Note 21 to the Consolidated Financial Statements. Prior to April 1, 2003, we
accounted for our plans under the recognition and measurement provisions of APB Opinion No. 25,
Accounting for Stock Issued to Employees, and related interpretations. No stock-based employee
compensation cost was reflected in previously reported results, as all options granted under those
plans had an exercise price equal to the market value of the underlying equity shares on the date
of grant. During the first quarter of fiscal 2004, we adopted the fair value recognition provisions
of SFAS No. 123, Accounting for Stock- Based Compensation, for stock-based employee compensation.
We have selected the retroactive method of adoption described in SFAS No. 148 Accounting for Stock
Based Compensation Transition and Disclosure for all options granted after January 1, 1995.
Consequently, for the years ended March 31, 2003, 2004 and 2005, an amount of Rs.128.5 million,
Rs.122.2 million and Rs.144.0 million respectively, has been recorded as total employee stock based
compensation expense.
During fiscal 2004, Aurigene Discovery Technologies Limited adopted two stock based employee
compensation plans, which are described more fully in Note 21 to the Consolidated Financial
Statements. We have accounted for these plans under SFAS No. 123, using the Black Scholes option
pricing model to determine the fair value of each option grant.
Deferred Taxes
50
Deferred taxes are accounted for using the asset and liability method. Deferred tax assets and
liabilities are recognized for the future tax consequences attributable to differences between the
financial statement carrying amounts of existing assets and liabilities and their respective tax
bases and operating loss carry-forwards. Deferred tax assets and liabilities are measured using
enacted tax rates expected to apply to taxable income in the years in which those temporary
differences are expected to be recovered or settled. The effect on deferred tax assets and
liabilities of a change in tax rates is recognized in the statement of operations in the period
that includes the enactment date. The measurement of deferred tax assets is reduced, if necessary,
by a valuation allowance for any tax benefits the future realization of which is uncertain.
Functional Currency
Our foreign subsidiaries have different functional currencies, determined based on the
currency of the primary economic environment in which they operate. For subsidiaries that operate
in a highly inflationary economy, the functional currency is determined as the Indian rupee. Due to
various subsidiaries operating in different geographic locations, a significant level of judgment
is involved in evaluating the functional currency for each subsidiary.
In respect of our foreign subsidiaries which market our products in their respective
countries/regions, the functional currency has been determined as Indian rupee, based on an
individual and collective evaluation of the various economic factors listed below.
The operations of these foreign subsidiaries are largely restricted to importing finished
goods from us in India, sale of these products in the foreign country and remitting the sale
proceeds to us. The cash flows realized from sale of goods are readily available for remittance to
us and cash is remitted to us on a regular basis. The costs incurred by these subsidiaries are
primarily the cost of goods imported from us. The financing of these subsidiaries is done directly
or indirectly by us.
In respect of other subsidiaries, the functional currency is determined as the local currency,
being the currency of the primary economic environment in which they operate.
Income Taxes
As part of the process of preparing our financial statements, we are required to estimate our
income taxes in each of the jurisdictions in which we operate. We are subject to tax assessments in
each of these jurisdictions. A tax assessment can involve complex issues, which can only be
resolved over extended time periods. Additionally, the provision for income tax is calculated based
on our assumptions as to our entitlement to various benefits under the applicable tax laws in the
jurisdictions in which we operate. The entitlement to such benefits depends upon our compliance
with the terms and conditions set out in these laws. Although we have considered all these issues
in estimating our income taxes, there could be an unfavorable resolution of such issues that may
affect our results of operations.
We also assess the temporary differences resulting from differential treatment of certain
items for tax and accounting purposes. These differences result in deferred tax assets and
liabilities, which are recognized in our consolidated financial statements. We also assess our
deferred tax assets on an ongoing basis by assessing our valuation allowance we consider the future
taxable incomes and the feasibility of tax planning initiatives. If we estimate that the deferred
tax assets cannot be realized at the recorded value, a valuation allowance is created with a charge
to the statement of income in the period in which such assessment is made.
Litigation
We are involved in various lawsuits, claims, investigations and proceedings, including ANDA
filings and other patent and commercial matters, which arise in the ordinary course of our
business. However, we evaluate specific risks related to the foregoing based on current conditions
and, at the balance sheet date, there are no such matters pending that we expect to be material in
relation to our business.
5.B. Liquidity and capital resources
Liquidity
51
We have primarily financed our operations through cash flows generated from operations and, to
a lesser extent, through short-term borrowings for working capital. Our principal liquidity and
capital needs are for making investments, the purchase of property, plant and equipment, regular
business operations and drug discovery.
Our principal sources of short-term liquidity are our existing cash and internally generated
funds, which we believe are sufficient to meet our working capital requirements and anticipated
capital expenditures over the near term. As part of our growth strategy, we continue to review
opportunities to acquire companies, complementary technologies or product rights. To the extent
that any such acquisitions involve significant cash payments, rather than the issuance of shares,
we may need to borrow from banks or raise additional funds from the debt or equity markets.
The following table summarizes our statements of cash flows for the periods presented:
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Fiscal
Year Ended March 31, |
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2003 |
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2004 |
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2005 |
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2005 |
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(Rs. in million, U.S.$ in thousands) |
Net cash provided by /(used in): |
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Operating activities |
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Rs.4,366.7 |
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Rs.3,999.2 |
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Rs.2,291.6 |
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U.S.$52,536 |
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Investing activities |
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(1,954.7 |
) |
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(6,506.1 |
) |
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632.9 |
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14,509 |
|
Financing activities |
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(153.0 |
) |
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(376.1 |
) |
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1,931.3 |
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44,276 |
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Effect of exchange rate changes on cash |
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(95.0 |
) |
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(14.2 |
) |
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55.8 |
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1,279 |
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Net increase / (decrease) in cash and cash
equivalents |
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Rs.2,164.0 |
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Rs.(2,897.2 |
) |
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Rs.4,911.6 |
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U.S.$112,600 |
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|
|
|
|
|
|
|
|
Cash Flow From Operating Activities
Net cash provided by operating activities decreased from Rs.3,999.2 million in fiscal 2004 to
Rs.2,291.6 million in fiscal 2005. Net cash provided by operating activities consisted primarily
of net income including adjustments for non-cash items and changes in working capital.
Our cash flow from operating activities decreased primarily due to a decrease in net income in
fiscal 2005 to Rs.211.2 million, as compared to Rs.2,474.2 million in fiscal 2004. Our net
working capital decreased by Rs.401.6 million, primarily due to inflows from higher collections
from customers, receipt of Rs.985.4 million under the agreement with I-VEN Pharma Capital Limited
and outflows on account of a decrease in trade payables and an increase in inventories by Rs.468
million. The reduction in trade payables was primarily due to the reduction in days of credit
outstanding for trade creditors for fiscal 2005 and the increase in inventories was primarily due
to higher purchases in anticipation of sales in our formulations and active pharmaceutical
ingredients and intermediates businesses.
Cash Flow From Investment Activities
Cash inflow from investment activities was Rs.618.3 million for the fiscal year ended March
31, 2005, primarily due to redemption of investment securities amounting to Rs.2,225.3 million.
This increase was partially offset by expenditures in property, plant and equipment amounting to
Rs.727.2 million and the acquisition of Trigenesis Therapeutics Inc. for Rs.535.7 million.
Cash Flows From Financing Activities
Net cash provided by financing activities for the fiscal ended March 31, 2005 was Rs.1,931.3
million primarily due to short-term borrowings in foreign currency from banks amounting to
Rs.2,520.0 million. This was partially offset by repayment of long-term debt amounting to Rs.157.5
million and dividends paid during the year amounting to Rs.431.6 million.
Principal obligations
The following table summarizes our principal debt obligations outstanding as of March 31,
2005:
52
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Payments due by period |
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(Rs. in millions) |
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|
Financial Contractual |
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|
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|
|
Less than |
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|
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|
|
|
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After |
|
|
Obligations |
|
Total |
|
1 year |
|
1-3 years |
|
3-5 years |
|
5 years |
|
Annual Interest Rate |
|
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LIBOR + 60 to 65bps |
|
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for FC denominated |
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loans and 10.25% |
Short-term borrowings |
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for Indian Rupee |
from banks |
|
|
2,796.3 |
|
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|
2,796.3 |
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|
borrowings |
Long term debt |
|
|
31.1 |
|
|
|
5.9 |
|
|
|
11.8 |
|
|
|
11.8 |
|
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|
1.6 |
|
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|
2 |
%* |
|
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|
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|
|
|
|
|
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|
|
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|
....current portion |
|
|
5.9 |
|
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|
5.9 |
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|
|
|
|
|
|
|
|
|
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|
....Non current portion |
|
|
25.2 |
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11.8 |
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11.8 |
|
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1.6 |
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* |
|
Loan received at a subsidized rate of interest from Indian Renewable Energy Development Agency
Limited promoting use of alternative sources of energy. |
Subject to obtaining certain regulatory approvals, there are no legal or economic
restrictions on the transfer of funds between us and our subsidiaries or for the transfer of funds
in the form of cash dividends, loans or advances.
The maturities of our short-term borrowings from banks vary from one month to approximately
six months. Our objective in determining the borrowing maturity is to ensure a balance between
flexibility, cost and the continuing availability of funds. All of our debts except for short-term
working capital loans from banks are at fixed rates of interest.
Cash and cash equivalents are held in Indian rupees, U.S. dollars, U.K. pounds sterling,
Singapore dollars, Brazilian real, Euros, Russian roubles, Chinese yuan, South African rand and
Hong Kong dollars.
As of March 31, 2004 and 2005, we had committed to spend approximately Rs.418.0 million and
Rs.192.2 million, respectively, under agreements to purchase property and equipment and other
capital commitments. These amounts are net of capital advances paid in respect of such purchases
and we anticipate funding them from internally generated funds.
5.C. Research and development, patents and licenses, etc.
Research and Development
Our research and development activities can be classified into several categories, which run
parallel to the activities in our principal areas of operations:
|
|
Formulations, where our research and development activities are
directed at the development of product formulations, process
validation, bioequivalency testing and other data needed to
prepare a growing list of drugs that are equivalent to numerous
brand name products for sale in the emerging markets. |
|
|
Active pharmaceutical ingredients and intermediates, where our
research and development activities concentrate on development of
chemical processes for the synthesis of active pharmaceutical
ingredients for use in our generics and formulations segments and
for sales in the emerging and developed markets to third parties. |
|
|
Generics, where our research and development activities are
directed at the development of product formulations, process
validation, bioequivalency testing and other data needed to
prepare a growing list of drugs that are equivalent to numerous
brand name products whose patents and regulatory exclusivity
periods have expired or are nearing expiration in the regulated
markets of the United States and Europe. |
During fiscal 2004, we integrated the product development capabilities in our API, generics and
formulations segments to increase our focus on productivity and product delivery, by combining
technical excellence with process excellence. We also strengthened our technical, intellectual
property and legal skills to enhance our new product development process. This will help us
leverage our core technology strengths in chemistry and formulation development with legal,
regulatory and intellectual property management expertise to expand our product pipeline.
|
|
Critical care and biotechnology, where research and development activities are directed at
the development of oncology and biotechnology products for the emerging as well as regulated
markets. Our new biotechnology research and development facility caters to the highest
development standards, including cGMP, Good Laboratory Practices
|
53
and bio-safety level IIA). We are in the process of building our bio-generics pipeline. During
fiscal 2005, we entered into an agreement with a U.S. based biotechnology company for the
development of a bio-generics portfolio.
|
|
Custom pharmaceutical services, where we intend
to leverage the strength of our process chemistry
and finished dosage development expertise to
target innovator as well as emerging
pharmaceutical companies. The research and
development is directed toward providing services
to support the entire pharmaceutical value chain
from discovery all the way to the market. |
|
|
Drug discovery, where we are actively pursuing
discovery and development of NCEs. Our research
programs focus on the following therapeutic
areas: |
|
o |
|
Metabolic disorders |
|
|
o |
|
Cardiovascular disorders |
|
|
o |
|
Cancer |
|
|
o |
|
Bacterial infections |
In fiscal 2003, 2004 and 2005, we expended Rs.1,411.8 million, Rs.1,991.6 million and
Rs.2,803.3 million, respectively, on research and development activities.
Patents, Trademarks and Licenses
We have filed and been issued several patents in our principal areas of operations: drug
discovery, active pharmaceutical ingredients and intermediates and generics. We expect to continue
to file patent applications seeking to protect our innovations and novel processes in several
countries, including the United States. Any existing or future patents issued to or licensed by us
may not provide us with any competitive advantages for our products or may even be challenged,
invalidated or circumvented by our competitors. In addition, such patent rights may not prevent our
competitors from developing, using or commercializing products that are similar or functionally
equivalent to our products. We have filed over 600 trademarks with the Registrar of Trademarks in
India. We also have made application for registration for non-U.S. trademarks in other countries in
which we do business. We market several products under licenses in several countries where we
operate.
5.D. Trend information
Fiscal year 2006 will be another challenging year for us as we continue to implement our long-term
strategy of being a discovery-led global pharmaceutical company.
Formulations. According to the Operations Research Group International Medical Statistics (ORG
IMS) Annual Report 2004, the Indian retail pharmaceutical market, valued at Rs.205 billion for the
twelve-month period ending December 31, 2004, grew by 6.4%. Much of this growth was driven by the
contribution from new products launched in the 24 month period ending on December 31, 2004.
Downward pressure on prices continues to negatively impact the market, although the magnitude of
the resulting decline in prices has gone down to 0.2% as compared to 0.7% in 2003.
Some of the readily apparent changes in our industry are as follows:
|
§ |
|
Introduction of the product patent regime with effect from January 1, 2005 |
|
|
§ |
|
Implementation of the Value Added Tax (VAT) system with effect from April 1, 2005 |
|
|
§ |
|
Introduction of the Maximum Retail Price (MRP) based excise duty structure for the pharmaceutical industry |
|
|
§ |
|
Higher investments of Indian companies in research and development as well as in new product launches |
|
|
§ |
|
Improvement in performance of multi-national corporations (MNCs) and increasing
interest of top global innovators as well as generic companies in India |
In 2004, although Indian based companies dominated the Indian market with 77% of the market share,
the MNCs improved their performance. The implementation of the product patent regime has triggered
MNCs to enter or plan to enter the market. The top global MNCs have established a direct or
indirect presence in India either through product introduction for sales and marketing,
establishment of manufacturing facilities or alliances with existing manufacturing facilities and
entry into new segments like clinical research organizations and biotechnology. During fiscal 2005,
key global generic players also evidenced greater interest in establishing manufacturing presence
in India. The market is also undergoing a
54
change in the way that Indian companies are operating. Indian companies have formed alliances with
partners to leverage on their core strengths and consolidate operations. The results of the
consolidation efforts are seen in the increased market share realized by the top ten Indian
pharmaceutical companies in the last two years. Along with the changes in the competitive
structure, the market has also shifted towards lifestyle disorders as the ailment pattern in India
has migrated to lifestyle disorders. It is notable that chronic therapies now account for close to
24% of the market and was growing at the end of 2004 at 12% per year. While the growth of our
revenues in India for fiscal 2005 was below industry average, in fiscal 2006, the momentum of our
new product launches in the last three years including fiscal 2006 as well as the recovery from the
loss of sales in March 2005 due to the implementation in India of the value added tax is expected
to drive revenue growth.
On
March 22, 2005, the government of India passed the Patents
(Amendment) Bill 2005 (the Amendment), introducing a
product patent regime for food, chemicals and pharmaceuticals in India. The Amendment specifically provides that new medicines
(patentability of which is not specifically excluded) for which a patent has been applied for in
India on or after January 1, 1995 and for which a patent is
granted cannot be manufactured or sold in India by other than the
patent holder and its assignees and licensees. This will result in a
reduction of the new product introductions in India, as well as other
countries where a similar legislation has been introduced, for all Indian
pharmaceutical companies engaged in the development and marketing of generic finished dosages and
APIs. Processes for the manufacture of APIs and formulations
were patentable in India even prior to the Amendment, so no
additional impact is anticipated from patenting of such processes.
The competitive environment in the emerging markets (outside India) is changing with most
countries moving towards recognizing product patents. This has the effect of reducing the window of
opportunity for new product launches. In order to compete effectively in such a challenging
environment, we are focusing on both our key therapeutic categories on a global basis and niche
therapeutic segments. As part of our global business development program, we will continue to
explore in-licensing and other opportunities to strengthen our product pipeline. In addition, we
will continue to consolidate and expand our presence in Russia and other countries of the former
Soviet Union.
Active Pharmaceutical Ingredients and Intermediates. In this segment, we are focused on the
regulated markets of North America and Europe.
In North America and Europe, we do not anticipate commencing any significant sales of new
products in fiscal 2006. The success of our existing API products in our key markets is contingent
upon the extent of competition in the generics market, which we anticipate will continue to be
significant.
Generics. In this segment, we are focused on the regulated markets of North America and
Europe. During fiscal 2005, in the United States, our key products of fluoxetine and tizanidine
were subjected to additional competition from existing market participants and this impacted the
sales of these two products. In fiscal 2006, while we do not anticipate commencing any significant
sales of new products, the success of our existing products is contingent upon the extent of
competition in the generics market, which we anticipate will continue to be significant. Further,
we expect that we will continue to expand our product pipeline for North America as well as Europe.
As of March 31, 2005, we had 45 ANDAs pending approval with the U.S. FDA. This includes 29 patent
challenges. The launch of these products is contingent upon the successful outcome of litigation
related to such products.
Critical Care and Biotechnology. We expect that we will continue to market our existing
products and develop additional products. The success of our existing products is contingent upon
the extent of competition in this segment.
Drug Discovery. During fiscal 2005, we commenced the second international clinical development
for our internally discovered New Chemical Entity (NCE) known as RUS 3108, our drug candidate for
the treatment of atheroslerosis. As of March 31, 2005, we had concluded Phase I clinical trials on
DRF 10945, our drug candidate for the treatment of dyslipidemia, while the Phase I clinical trials
on RUS 3108, our drug candidate for the treatment of atheroslerosis were in progress in Ireland. As
we make progress in advancing our pipeline into development, we are building capabilities in drug
development. We believe this will help to enhance the value of our NCE assets. We expect to further
complement our internal research and development efforts by pursing strategic partnerships and
alliances in our key focus areas.
R&D Alliances. During fiscal 2005, we entered into a U.S.$56 million partnership with I-VEN
Pharma Capital Limited (I-VEN) for commercialization of certain of our U.S. ANDAs. I-VEN will
contribute to the funding of the development, registration and legal costs related to the
commercialization of most of the U.S. ANDAs filed or to be filed in 2004-2005 and 2005-2006 on a
pre-determined basis. Upon the commercialization of these products, we will pay I-VEN a royalty on
net sales for a period of five years. I-VEN has already invested U.S.$22.5 million as of March 31,
2005, and has the option to invest an additional U.S.$33.5 million, in which event I-VEN will be
entitled to additional royalties. We have recognized U.S.$2.2 million from the initial investment of
U.S. $22.5 million as a reduction in our research and
55
development expenses for fiscal 2005. A significant portion of the balance of such initial
investment is available to reduce the research and development expenses based on the ANDA filing
program and litigation milestones for fiscal 2006. Going forward, we will attempt to structure
similar mutually beneficial arrangements for reducing our development risks in our Drug Discovery
and Specialty businesses.
5.E. Off-Balance Sheet Arrangements
Guarantees. We adopted the provisions of Financial Accounting Standards Board (FASB)
Interpretation No. 45, Guarantors Accounting and Disclosure Requirements for Guarantees, including
Indirect Guarantees of Indebtedness of Others. The Interpretation requires that we recognize the
fair value of guarantee and indemnification arrangements issued or modified by us after December
31, 2002, if these arrangements are within the scope of that Interpretation.
In addition, under previously existing generally accepted accounting principles, we continue
to monitor the conditions that are subject to the guarantees and indemnifications to identify
whether it is probable that a loss has occurred, and would recognize any such losses under the
guarantees and indemnifications when those losses can be estimated.
We have only one guarantee, which was given on behalf of Pathnet India Private Limited (our
joint venture with Gribbles Pathology of Australia). Pathnet, an equity investee accounted for by
the equity method, secured a financial assistance of Rs.250 million from ICICI Bank Ltd. (ICICI
Bank). To enhance the credit standing of Pathnet, on December 14, 2001 we issued a corporate
guarantee of Rs.122.5 million in favor of ICICI Bank. In July 2005, we were released by ICICI Bank
from this guarantee when our share of outstanding loan amount, Rs.21.0 million, was repaid.
5.F. Tabular Disclosure of Contractual Obligations
The following summarizes our contractual obligations as of March 31, 2005 and the effect such
obligations are expected to have on our liquidity and cash flows in future periods.
|
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|
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|
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|
|
|
Payments Due by Period |
|
|
(Rs. in millions) |
|
|
|
|
|
|
Less than |
|
|
|
|
|
|
|
|
|
After |
|
|
Total |
|
1 year |
|
1-3 years |
|
3-5 years |
|
5 years |
Financial contractual obligations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating lease obligations |
|
Rs. |
591.2 |
|
|
|
74.6 |
|
|
|
149.8 |
|
|
|
139.5 |
|
|
|
227.3 |
|
|
|
|
|
|
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|
|
|
|
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|
|
Purchase obligations |
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Agreements to purchase property
and equipment and other capital
commitments(1) |
|
|
192.2 |
|
|
|
192.2 |
|
|
|
|
|
|
|
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|
|
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|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Borrowings from banks |
|
|
2,796.3 |
|
|
|
2,796.3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long term debt |
|
|
31.1 |
|
|
|
5.9 |
|
|
|
11.8 |
|
|
|
11.8 |
|
|
|
1.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
....current portion |
|
|
5.9 |
|
|
|
5.9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
....non current portion |
|
|
25.2 |
|
|
|
|
|
|
|
11.8 |
|
|
|
11.8 |
|
|
|
1.6 |
|
|
|
|
(1) |
|
These amounts are net of capital advances paid in respect of such purchases and are expected to
be funded from internally generated funds. |
56
ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES
6.A. Directors and senior management
The list of our directors and executive officers, their respective age and position as of
March 31, 2005 are as follows:
Directors
|
|
|
|
|
|
|
Name(1) |
|
Age (in yrs) |
|
Position |
Dr. K. Anji Reddy(2)
|
|
|
65 |
|
|
Chairman |
Mr. G. V. Prasad(2),(3)
|
|
|
44 |
|
|
Chief Executive Officer and Executive Vice Chairman |
Mr. Satish Reddy (2),(4)
|
|
|
37 |
|
|
Chief Operating Officer and Managing Director |
Mr. Anupam Puri
|
|
|
59 |
|
|
Director |
Prof. Krishna G. Palepu
|
|
|
52 |
|
|
Director |
Dr. Omkar Goswami
|
|
|
48 |
|
|
Director |
Mr. P.N. Devarajan
|
|
|
69 |
|
|
Director |
Mr. Ravi Bhoothalingam
|
|
|
58 |
|
|
Director |
Dr. V. Mohan
|
|
|
50 |
|
|
Director |
|
|
|
(1) |
|
Except for Dr. K. Anji Reddy, Mr. G.V. Prasad and Mr. Satish Reddy, all of the directors
are independent directors as defined under the New York Stock Exchange Corporate Governance
guidelines and the U.S. Sarbanes Oxley Act of 2002. |
|
(2) |
|
Full-time director. |
|
(3) |
|
Son-in-law of Dr. K Anji Reddy. |
|
(4) |
|
Son of Dr. K Anji Reddy. |
Executive Officers
Our policy is to classify our officers as executive officers if they have membership on our
Management Council. Our Management Council consists of various business and functional heads and is
our senior management organization. As of March 31, 2005, the Management Council consisted of:
|
|
|
|
|
|
|
Name |
|
Age (in yrs) |
|
Position |
Mr. G.V. Prasad(1)
|
|
|
44 |
|
|
Chief Executive Officer and Vice Chairman |
Mr. Satish Reddy(2)
|
|
|
37 |
|
|
Chief Operating Officer and Managing Director |
Mr. V.S. Vasudevan
|
|
|
53 |
|
|
Chief Financial Officer |
Mr. Abhijit Mukherjee
|
|
|
46 |
|
|
President Developing Businesses |
Mr. Alan Shepard
|
|
|
57 |
|
|
Executive Vice President Europe |
Mr. Andrew Miller
|
|
|
49 |
|
|
Executive Vice President and General Counsel |
Mr. Arun Sawhney
|
|
|
50 |
|
|
President API |
Mr. Ashwani Kumar Malhotra
|
|
|
49 |
|
|
Senior Vice President Formulations Manufacturing |
Dr. Dennis Langer(3)
|
|
|
54 |
|
|
President North America |
Mr. Jaspal Singh Bajwa
|
|
|
52 |
|
|
President Branded Formulations (Rest of the World(4)) |
Mr. K.B. Sankara Rao
|
|
|
51 |
|
|
Executive Vice President Integrated Product Development |
Mr. Mark Hartman
|
|
|
46 |
|
|
Executive Vice President North America Generics |
Mr. Osagie O. Imasogie(5)
|
|
|
44 |
|
|
Executive Vice President Global Corporate Business Development |
Dr. R. Rajagopalan
|
|
|
54 |
|
|
President Discovery Research |
Mr. Raghu Cidambi
|
|
|
54 |
|
|
Advisor and Head Corporate Intellectual Property Management and Strategic Planning |
Mr. Saumen Chakraborty
|
|
|
43 |
|
|
Executive Vice President and Global Chief of Human Resources |
Dr. Uday Saxena
|
|
|
47 |
|
|
Chief Scientific Officer |
|
|
|
(1) |
|
Son-in-law of Dr. K Anji Reddy. |
|
(2) |
|
Son of Dr. K Anji Reddy. |
|
(3) |
|
Ceased to be our employee as of July 8, 2005 |
|
(4) |
|
Does not include North America and Europe |
|
(5) |
|
Ceased to be employee as of June 30, 2005 |
In addition, Mr. Jeff Wasserstein joined our Management Council on July 8, 2005. He is
working with us as Executive Vice President North America Specialty.
Biographies
Directors
57
Dr. K. Anji Reddy is our Founder and Chairman of our Board of Directors. He is also the
Founder of Dr. Reddys Research Foundation and Dr. Reddys Foundation for human and social
development. He has an undergraduate degree in Technology of Pharmaceuticals and Fine Chemicals
from the University of Bombay and a Ph.D. in Chemical Engineering from National Chemical
Laboratories, Pune. He has six years experience with Indian Drugs and Pharmaceuticals Limited
(IDPL) in the manufacture and implementation of new technologies in bulk drugs. He is a member of
the Board of Trade as well as the Prime Ministers Task force on pharmaceuticals and
knowledge-based industries. The Government of India bestowed the Padmashri Award upon him for his
distinguished service in the field of trade and commerce. In addition to positions held with our
subsidiaries and joint ventures, he is a Director in Diana Hotels Limited, OOO JV Reddy Biomed
Limited, and Pathenco APS.
Mr. G. V. Prasad is a member of our Board of Directors and serves as our Executive
Vice-Chairman and Chief Executive Officer. He was the Managing Director of Cheminor Drugs Limited,
a Dr. Reddys Group Company, prior to its merger with us. He has a Bachelor of Science degree in
Chemical Engineering from Illinois Institute of Technology, Chicago, U.S.A. and an M.S. in
Industrial Administration from Purdue University, U.S.A. He is also an active member of several
associations including the National Committee on Drugs & Pharmaceuticals. In addition to positions
held with our subsidiaries and joint ventures, he is a Director of Diana Hotels Limited, Nipuna
Services Limited and Leiner Health Products, LLC.
Mr. Satish Reddy is a member of our Board of Directors and serves as our Managing Director and
Chief Operating Officer. He has a Master of Science degree in Medicinal Chemistry from Purdue
University, U.S.A. and a Bachelor of Technology degree in Chemical Engineering from Osmania
University, Hyderabad. He is the member of the Confederation of Indian Industries for Andhra
Pradesh. In addition to positions held with our subsidiaries and joint ventures, he is also a
Director of Diana Hotels Limited and OOO JV Reddy Biomed Limited.
Mr. Anupam Puri has been a member of our Board of Directors since 2002. He retired from
McKinsey & Company in late 2000. He was a Director and played a variety of other leadership roles
during his 30-year career there. Before joining McKinsey & Company, he was Advisor for Industrial
Development to the President of Algeria, and consultant to General Electrics Center for Advanced
Studies. He holds a Bachelor of Arts degree in Economics from St. Stephens College, Delhi
University, and Master of Arts and M. Phil. degrees from Oxford University. He is also on the
Boards of Godrej Consumer Products Limited, ICICI Bank Limited, Mahindra and Mahindra Limited,
Mahindra British Telecom Limited and Patni Computer Systems Limited.
Professor Krishna G. Palepu has been a member of our Board of Directors since 2002. He is the
Ross Graham Walker Professor of Business Administration at the Harvard Business School. He holds
the title of Senior Associate Dean, Director of Research. Professor Palepu has a Masters degree in
physics from Andhra University, an M.B.A. from the Indian Institute of Management and a Ph.D. from
the Massachusetts Institute of Technology. He is also a recipient of an honorary M.A. from Harvard,
and an honorary Doctorate from the Helsinki School of Economics. He teaches finance, control and
strategy in Harvards M.B.A. and Executive programs. He has published numerous research papers and
is also the co-author of the book titled Business Analysis & Valuation: Text and Cases. He serves
as a consultant to a wide variety of businesses and is on the boards of Satyam Computer Services
Limited, Exetor Group, Enamics Limited and Harvard Business School Publishing Company.
Dr. Omkar Goswami has been a member of our Board of Directors since 2000. He is a founder and
Chairman of CERG Advisory Private Limited, a corporate advisory and economic research and
consulting company. He was a senior consultant and chief economist at the Confederation of Indian
Industry for six years. He has also served as editor of Business India, associate professor at the
Indian Statistical Institute, Delhi, and as an honorary advisor to the Ministry of Finance. He
holds a Bachelor of Economics degree from St. Xaviers College, Calcutta University, a Master of
Economics degree from the Delhi School of Economics, Delhi University and a Ph.D. degree from
Oxford University. He is also a director of Infosys Technologies Limited, DSP-Merrill-lynch
Investment Managers Limited, Crompton Greaves Limited, Infrastructure Development Finance Company
Limited, SRF Limited and Sona Koyo Steering Systems Limited.
Mr. P.N. Devarajan has been a member of our Board of Directors since 2000. He has previously
served as a Director of Cheminor Drugs Limited. He is also currently a member of the Planning Board
of Madhya Pradesh, Chairman of Research at the Council of National Environment Engineering Research
Institute, member of the Assessment Committee of the Council of Scientific and Industrial Research
and a member of the Research Council of National Chemical Laboratory. He has previously served as a
Director of the Bank of Baroda, a member of the Central Board of Directors of the Reserve
58
Bank of India and Group President and consultant of Reliance Industries Limited. He is also a
Director on the Board of Kothari Sugars and Chemicals Limited.
Mr. Ravi Bhoothalingam has been a member of our Board of Directors since 2000. He has served
as the President of The Oberoi Group and was responsible for its worldwide operations. He has also
served as the Head of Personnel at BAT Plc, Managing Director of VST Industries Limited, and as a
Director of ITC Limited. He holds a Bachelor of Science degree in physics from St. Stephens
College, Delhi and a Master of experimental psychology degree from Gonville and Caius College,
Cambridge University. He is also a Director of Nicco Internet Ventures Limited and Sona Koyo
Steering Systems Limited.
Dr. V. Mohan has been a member of our Board of Directors since 1996. He is also a visiting
professor of Diabetology at Sri Ramachandra Medical College and a professor of International Health
at the University of Minnesota, U.S.A. He holds a Bachelor of Medicine degree, Doctor of Medicine
degree, Ph.D. and a Doctor of Science degree from Madras University. He was awarded the prestigious
Dr. B.C. Roy National Award by the Medical Council of India in 2005 . He is also the
Chairman and Managing Director of M.V. Diabetes Specialties Centre Private Limited and the
President of the Madras Diabetes Research Foundation.
Executive Officers
Mr. V S Vasudevan is our Chief Financial Officer. In this position he is responsible for
managing the finance teams of us and our group of companies worldwide. He also heads the
Secretarial, Legal, Investor Relations and Internal Audit functions. He has played an important
role in establishment of our corporate governance framework. Under his leadership, we have
received external recognition for our corporate governance and financial reporting practices from
the Institute of Company Secretaries of India and the Institute of Chartered Accountants of India.
He has played a key role in the integration of Cheminor Drugs Limited with us and in our growth
through various corporate initiatives, including acquisition of companies in India and overseas and
acquisition of brands in India. He is a Chartered Accountant by qualification, and a member of the
Peer Review Board of the Institute of Chartered Accountants of India.
Mr. Abhijit Mukherjee is our President of Developing Businesses. Before joining us, he worked
with Atul Limited for 10 years, where he held numerous positions of increasing responsibility. In
his last assignment there he was President, Bulk Chemicals and Intermediates Business, and Managing
Director, Amal Products Limited. He started his career as a management trainee in Hindustan Lever
Limited (HLL) and put in 13 years in that company including 3 years in a Unilever company. He was
primarily involved in the technical assignments in Aroma chemicals business in HLL and Unilever and
also in detergents and sulphonation plants of HLL. He is a graduate in Chemical Engineering from
the Indian Institute of Technology, Kharagpur.
Mr. Alan Shepard is our Executive Vice President Europe Business. He joined us from Pliva,
where he was Vice President for Global Corporate Strategy. He has a unique combination of
experience in areas of commercial, general management, research and development, manufacturing and
strategic planning across a variety of product lines, including generics, ethical branded, over the
counter and vaccines. He has been associated with several pharmaceutical companies and held several
management positions such as General Manager of RhonePoulenc Rorer (now Aventis), European
Marketing Director for Medeva and held various positions with Institute Merieux, Smith Kline and
Upjohn. He has a Bachelors of Technology (Honors) degree from Bradford University and is an
honorary lecturer for the University of Wales Medical faculty. He has served on several U.K.
government committees and been a long-standing member of the Association of British Pharmaceutical
Industrys code of practice committee.
Mr. Andrew Miller is Executive Vice President Legal and Intellectual Property Management. He
is also a principal at Budd Larner, P.C., our legal counsel in the U.S. He has represented us since
the formation of our first U.S. entity in 1992. He is a graduate of the University of Michigan Law
School where he was an Editor of Michigans Journal of Law Reform. He holds a B.A. degree from the
State University of New York at Buffalo, where he graduated summa cum laude in 1977 and was elected
a member of Phi Beta Kappa.
Mr. Arun Sawhney is President of our Europe and Global API businesses. He joined us in 2001 as
President of our API business from Max-GB Limited, where he was Chief Executive. Prior to that he
headed the Global Business Development function at Ranbaxy Laboratories Limited. He has also had
successful stints as Manager Exports with Hindustan Ciba Geigy and as Regional Sales Manager with
Bayer India, earlier in his career. He is a silver medalist, holds an MBA from
59
the International Management Institute, New Delhi, and a Bachelors degree in Commerce from
Sydenham College of Commerce and Economics, Mumbai.
Mr. Ashwani Kumar Malhotra is Senior Vice President of our Formulations manufacturing
operations. He joined us as Vice President in February 2001, and was responsible for the India
operations supporting Generics and Specialty businesses with new product development filings and
manufacturing and supply of products to regulated markets such as the U.S., Canada, Europe, the
U.K., South Africa, Australia and New Zealand. Prior to joining us, he worked with Cipla Limited
for 13 years in various capacities and with Warner Hindustan, a division of Parke Davis in
formulations development and manufacturing for 7 years. He holds a postgraduate degree in Pharmacy
from the Institute of Technology, Banaras Hindu University. He also holds a Diploma in Industrial
Engineering & Management and a Postgraduate Diploma in Computer Systems from the Institute of
Public Enterprises, Government of India.
Dr. Dennis Langer is President of our North America business operations. He joined us from
GlaxoSmithKline, Inc., where he was Senior Vice President, project and portfolio management,
research and development. He has a unique combination of experience in areas of innovation,
research and development, commercial operations and strategy and business development and has been
associated with several pharmaceutical companies such as Eli Lilly and Company Limited, Abbott
Laboratories and GD Searle & Company, Inc. where he held various senior management positions. He
was also Chief Resident in psychiatry at Yale University School of Medicine and held clinical
fellowships in psychiatry at Harvard Medical School, George Washington University School of
Medicine and the National Institutes of Health. He has a J.D. (cum laude) from Harvard Law School,
an M.D. from Georgetown University School of Medicine, and a B.A. in Biology from Columbia
University. He has to his credit several publications in peer reviewed medical journals. He
currently serves on the board of Transkaryotic Therapies, Inc. and the Boards of Visitors at
Columbia College, Columbia University and Georgetown University School of Medicine. He is a
Clinical Professor, Department of Psychiatry, Georgetown University School of Medicine, Washington,
D.C. Mr. Langer ceased to be our employee effective as of July 8, 2005.
Mr. Jaspal Singh Bajwa is President of our Branded Formulations (Rest of the World) business.
He joined us from Marico Industries, where he was Executive Director and Chief Operating Officer.
He has 26 years of diverse experience in the consumer and healthcare products industries, having
worked with Nestlé, S.A. and Bausch and Lomb, Inc. He started his career with Nestlé, S.A. After 15
years with Nestlé, S.A. in Sales and Marketing, his last position was Chief of Marketing in India.
Subsequently, he spent over 10 years with Bausch and Lomb, Inc., where he held several senior
management positions including those of Managing Director for India/ SAARC, and Head of their
Canadian Subsidiary. He has a Bachelors degree in Food Technology and an MBA from the Indian
Institute of Management, Ahmedabad.
Mr. K.B. Sankara Rao is Senior Vice President responsible for Integrated Product Development
for our Global Formulations, Generics and API businesses. He has been with us since 1986 in various
capacities, providing the initial impetus to our Formulations business by establishing the
manufacturing facilities and upgrading standards to the present day business needs which resulted
in the attainment of various statutory approvals, including in the U.K. MHRA approval. He is also
responsible for the design and implementation of the Self Managing Team concept in two of our
Formulations manufacturing units. He holds a Masters degree in Pharmacy from Andhra University. He
is a life member of the Indian Pharmaceutical Association amongst his other affiliations. He has
also been a member of CII-Southern Regional Quality & Productivity Sub-committee.
Mr. Mark Hartman is Executive Vice President of our North America Generics business. He has
17 years of experience in the pharmaceutical industry. Before joining us, Mark spent five years at
Watson Laboratories. His last three positions at Watson were Director of Marketing for Trade &
Managed Care, Executive Director, Sales & Marketing Watson Generics, and Vice President, Sales &
Marketing, Watson Generics. He was involved in multiple product and company acquisitions during his
tenure with Watson. Before Watson, he was Director of Marketing for Alpharma USPD, Marketing
Manager at Geneva Pharmaceuticals, and held various brand and generic sales and marketing positions
during his 10 years at Lederle Laboratories. He holds a bachelors degree in Dairy Science from
Virginia Tech, Virginia.
Mr. Osagie O. Imasogie is the Executive Vice President of Global Corporate Business
Development. Prior to joining us, he was Chief Executive Officer of Trigenesis Therapeutics Inc.
Prior to that he was Vice-President and Director, GSK Ventures, GlaxoSmithKline Research and
Development and was instrumental in the external value maximization of various GlaxoSmithKline
research and development assets, such as compounds, technology platforms, databases / libraries and
patents. He worked with Smithkline Beecham Corporation as a Senior Counsel for a short time before
becoming the founding General Counsel & Secretary, Endo Pharmaceuticals Inc., a start-up specialist
pharmaceutical company. As a
60
Senior Vice President, Business Development at Endo, he was responsible for all of Endos
Worldwide Business Development initiatives. A business executive and attorney, he has over 20 years
of professional experience in areas including the healthcare/pharmaceutical industry, business
development, corporate finance, corporate law, intellectual property and consulting with Price
Waterhouse, DuPont Merck Pharmaceutical Company and Genesiscorp Limited. He obtained his initial
legal education in Nigeria before earning his LL.M at the London School of Economics and another
LL.M from the University of Pennsylvania School of Law in Philadelphia. Mr. Imasogie ceased to be
our employee effective as of June 30, 2005
Dr. R. Rajagopalan is President of our Discovery Research segment. He started his career with
Hoechst India Ltd and was associated with their drug discovery program in various capacities for
over two decades. He was the principal research scientist in Hoechst when he chose to join us to
head our Pharmacology Research and Development group in 1994. He was instrumental in building the
discovery biology capabilities at Discovery Research and was promoted to Senior Vice-President,
Discovery Biology in 2000. He graduated in 1970 from Madras University with a Bachelors of Science
degree with chemistry as a major and obtained a Masters degree in Pharmacology at the same
university. He undertook Doctoral study in pharmacology at the Bombay University. He has several
research publications and patents to his credit.
Mr. Raghu Cidambi is Advisor and Head of Corporate Intellectual Property Management and
Strategic Planning. Prior to joining us, he served with the Eenadu Group, a large south India-based
media conglomerate, where he was responsible for its legal affairs. He has graduated from the
Indian Institute of Management, Calcutta and thereafter obtained a Bachelors Degree in Law from
the Osmania University in Hyderabad.
Mr. Saumen Chakraborty is Executive Vice-President and Global Chief of Human Resources (HR).
He has 16 years of experience in strategic and operational aspects of management. Prior to joining
us, he held various positions including line manager and a HR facilitator, with diverse portfolios
such as Senior Manager (Finance & Accounts) in Eicher, and Vice President (Operations) in Tecumseh.
A member of various industry fora including the CII and the National HRD Network, he graduated with
honors as the valedictorian of his class from Visva-Bharati University in Physics, and went on to
pursue management from Indian Institute of Management, Ahmedabad.
Dr. Uday Saxena is our Chief Scientific Officer. Since 2002, he has also been the President
and CEO of Reddy US Therapeutics, Inc., our subsidiary located in Atlanta, Georgia. Reddy US
Therapeutics, Inc. is engaged in drug discovery in the areas of diabetes, inflammation and
cardiovascular disease. He has been in the pharmaceutical/biotech industry for over a decade. From
1997 to early 2000, he was Vice President of Research and a member of the executive committee at
AtheroGenics, Inc, a publicly traded biopharmaceutical company located in Alpharetta, Georgia.
While at AtheroGenics, he directed several drug discoveries and early development programs that
lead to identification of novel compounds currently in late phase clinical trails for restenosis,
atherosclerosis and chronic inflammation. Prior to that he was at Parke-Davis Research Division,
Ann Arbor, Michigan, where he was responsible for establishing a discovery program in inflammation
and atherosclerosis.
Mr. Jeffrey Wasserstein is Executive Vice President of our North America Specialty business. He
joined us in January 2005. He focuses on building our specialty business in North America and in
addition works with the North American Management Team on selected opportunities for adding value
to our other businesses in North America. Prior to joining us he had a long career with Schering
Plough Corporation where he was Senior Vice President of Corporate Consent Decree Integration.
Prior to this role, he was the President of Schering Canada. He also held several positions of
increasing responsibility at the Vice President level over Corporate Business Development,
Strategic Planning & Internal Consulting and as Associate General Counsel-Commercial. Prior to
joining Schering Plough Corporation, he was an Associate Attorney with Wachtell, Lipton, Rosen &
Katz. He holds a Bachelor of Arts degree from Franklin & Marshall College and a J.D. degree from
New York University School of Law.
6.B. Compensation of directors and executive officers
Directors compensation
Full-Time Directors. The compensation of our Chairman, Chief Executive Officer and Chief
Operating Officer (who we refer to as our full-time directors) is divided into salary, commission
and benefits. The compensation committee of the Board of Directors initially recommends the
compensation for full-time directors. If the Board of Directors (the
61
Board) approves the recommendation, it is then submitted to the shareholders for approval at
the general shareholders meeting.
Our shareholders have approved the salary, benefits and maximum amount of commission for each
of our full-time directors. Our Chief Operating Officer and Chief Executive Officer are each
entitled to receive a maximum commission of up to 0.5% of our net profit (as defined under the
Indian Companies Act, 1956) for the fiscal year. Our Chairman is entitled to receive a maximum
commission of up to 1.0% of our net profit (as defined under the Indian Companies Act, 1956) for
the fiscal year. The compensation committee, which is composed of independent directors,
recommends the commission for our Chairman, Chief Executive Officer and Chief Operating Officer
within the limits of 1%, 0.5% and 0.5% respectively of the net profits (as defined under the Indian
Companies Act, 1956) for the fiscal year.
Non-Full Time Directors. Each of our non-full time directors receives an attendance fee of
Rs.5,000 (U.S.$115.2) for every Board meeting and Board committee meeting they attend. In fiscal
2005, we paid an aggregate of Rs.392 thousands (U.S.$8,986) to our non-full time directors as
attendance fees. Non-full time directors are also eligible to receive a commission on our net
profit (as defined under the Indian Companies Act, 1956) for the fiscal year. Our shareholders have
approved a maximum commission up to 0.5% of the net profits (as defined under the Indian Companies
Act, 1956) for the fiscal year for all non-full time directors in a year. The Board determines the
entitlement of each of the non-full time directors to commission within the overall limit.
For fiscal 2005, the directors were entitled to the following amounts as compensation:
Rs. in thousands
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Name of Directors |
|
Attendance fees |
|
Commission |
|
Salary |
|
Perquisites |
|
Total |
Dr. K. Anji Reddy |
|
NA |
|
|
4,337 |
|
|
|
1,800 |
|
|
|
144 |
|
|
|
6,281 |
|
Mr. G.
V. Prasad |
|
NA |
|
|
2,169 |
|
|
|
1,080 |
|
|
|
195 |
|
|
|
3,444 |
|
Mr. Satish Reddy |
|
NA |
|
|
2,169 |
|
|
|
1,080 |
|
|
|
195 |
|
|
|
3,444 |
|
Mr. Anupam Puri |
|
|
70 |
|
|
|
383 |
|
|
NA |
|
NA |
|
|
453 |
|
Prof.
Krishna G. Palepu |
|
|
57 |
|
|
|
383 |
|
|
NA |
|
NA |
|
|
440 |
|
Dr. Omkar Goswami |
|
|
80 |
|
|
|
383 |
|
|
NA |
|
NA |
|
|
463 |
|
Mr. P.
N. Devarajan |
|
|
100 |
|
|
|
383 |
|
|
NA |
|
NA |
|
|
483 |
|
Dr. P. Satyanarayana Rao(1) |
|
|
10 |
|
|
|
|
|
|
NA |
|
NA |
|
|
10 |
|
Mr. Ravi Bhoothalingam |
|
|
65 |
|
|
|
383 |
|
|
NA |
|
NA |
|
|
448 |
|
Dr. V. Mohan |
|
|
10 |
|
|
|
256 |
|
|
NA |
|
NA |
|
|
266 |
|
|
|
|
(1) |
|
Retired as Director at the annual General Meeting held on July 28, 2004. |
Stock Options to Directors. We introduced the Dr. Reddys Employee Stock Option Scheme,
2002 in fiscal 2002. Our full-time directors are not eligible to participate in this plan. None of
the non-full time directors were granted any options under this plan in fiscal 2005.
Executive officers compensation
The initial compensation to all our executive officers is determined through appointment
letters issued at the time of employment. The appointment letter provides the initial amount of
salary and benefits the executive officer will receive as well as a confidentiality provision and a
non-compete provision applicable during the course of the executive officers employment with us.
We provide salary, certain perquisites, retirement benefits, stock options and variable pay to our
executive officers. The compensation committee of the Board reviews the compensation of executive
officers on a periodic basis.
We also have an employee stock option scheme. The scheme is applicable to all of our employees
and directors and employees and directors of our subsidiaries. The scheme is not applicable to
promoter directors, promoter employees and persons holding 2% or more of our outstanding share
capital. The compensation committee of the Board of Directors awards options pursuant to the scheme
based on the employees performance appraisal. Some employees have also been granted options upon
joining us.
62
Compensation for executive officers who are full time directors is summarized in the table
under Directors compensation, above. The following table presents the annual compensation paid
for services rendered to us for fiscal 2005 and stock options held by all of our other executive
officers as of March 31, 2005:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Compensation |
|
Stock Options |
Name |
|
Rs. in Thousands |
|
Date of grant |
|
No. of options |
|
Exercise price |
|
Expiry Date |
Mr. V.S. Vasudevan |
|
|
7,213 |
|
|
|
05.09.2002 |
|
|
|
5,740 |
|
|
|
1,063.02 |
|
|
|
(2 |
) |
|
|
|
|
|
|
|
05.13.2003 |
|
|
|
10,000 |
|
|
|
883.00 |
|
|
|
(2 |
) |
|
|
|
|
|
|
|
05.27.2004 |
|
|
|
10,000 |
|
|
|
885.00 |
|
|
|
(2 |
) |
Mr. Abhijit Mukherjee |
|
|
5,834 |
|
|
|
01.24.2005 |
|
|
|
3,200 |
|
|
|
5.00 |
|
|
|
(2 |
) |
Mr. Alan Shepard(1) |
|
|
3,430 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
- |
|
Mr. Andrew Miller |
|
|
18,766 |
|
|
|
01.29.2002 |
|
|
|
30,000 |
|
|
|
977.30 |
|
|
|
01.28.2007 |
|
|
|
|
|
|
|
|
01.24.2005 |
|
|
|
6,800 |
|
|
|
5.00 |
|
|
|
(2 |
) |
Mr. Arun Sawhney |
|
|
9,289 |
|
|
|
01.24.2005 |
|
|
|
11,880 |
|
|
|
5.00 |
|
|
|
(2 |
) |
Mr. Ashwani Kumar
Malhotra |
|
|
5,160 |
|
|
|
01.24.2005 |
|
|
|
3,520 |
|
|
|
5.00 |
|
|
|
(2 |
) |
Dr. Dennis Langer |
|
|
16,968 |
|
|
|
01.19.2004 |
|
|
|
80,000 |
|
|
|
5.00 |
|
|
|
(2 |
) |
|
|
|
|
|
|
|
01.24.2005 |
|
|
|
12,000 |
|
|
|
5.00 |
|
|
|
(2 |
) |
|
|
|
|
|
|
|
02.18.2005 |
|
|
|
12,000 |
|
|
|
5.00 |
|
|
|
(2 |
) |
Mr. Jaspal Singh Bajwa |
|
|
9,203 |
|
|
|
01.24.2005 |
|
|
|
8,000 |
|
|
|
5.00 |
|
|
|
(2 |
) |
Mr. K.B. Sankara Rao |
|
|
4,941 |
|
|
|
01.24.2005 |
|
|
|
7,718 |
|
|
|
5.00 |
|
|
|
(2 |
) |
Mr. Mark Hartman |
|
|
16,464 |
|
|
|
05.09.2002 |
|
|
|
60,000 |
|
|
|
1,063.02 |
|
|
|
(3 |
) |
|
|
|
|
|
|
|
05.13.2003 |
|
|
|
10,000 |
|
|
|
883.00 |
|
|
|
(2 |
) |
|
|
|
|
|
|
|
05.27.2004 |
|
|
|
6,000 |
|
|
|
885.00 |
|
|
|
(2 |
) |
Mr. Osagie O.
Imasogie(2) |
|
|
12,275 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dr. R. Rajagopalan |
|
|
5,203 |
|
|
|
01.24.2005 |
|
|
|
9,680 |
|
|
|
5.00 |
|
|
|
(2 |
) |
Mr. Raghu Cidambi |
|
|
4,200 |
|
|
|
01.24.2005 |
|
|
|
8,000 |
|
|
|
5.00 |
|
|
|
(2 |
) |
Mr. Saumen Chakraborty |
|
|
6,594 |
|
|
|
05.13.2003 |
|
|
|
7,500 |
|
|
|
883.00 |
|
|
|
(2 |
) |
|
|
|
|
|
|
|
01.24.2005 |
|
|
|
7,200 |
|
|
|
5.00 |
|
|
|
(2 |
) |
Dr. Uday Saxena |
|
|
11,681 |
|
|
|
01.24.2005 |
|
|
|
8,000 |
|
|
|
5.00 |
|
|
|
(2 |
) |
|
|
|
(1) |
|
Joined in November 2004 |
|
(2) |
|
The expiry period is 5 years from the date of vesting. The options vest each year over a
period of 4 years. |
|
(3) |
|
The expiry period is 5 years from the date of vesting. The options vest each year over a
period of 3 years. |
Retirement benefits.
We provide the following benefit plans to our employees:
Gratuity benefits: In accordance with applicable Indian laws, we provide a defined benefit
retirement plan (the Gratuity Plan) covering all of our permanent employees. The Gratuity Plan
provides a lump sum payment to vested employees at retirement or termination of employment in an
amount based on the respective employees last drawn salary and the years of employment with us.
Effective September 1, 1999, we established Dr. Reddys Laboratories Gratuity Fund (the Gratuity
Fund). Liabilities with regard to the Gratuity Plan are determined by an actuarial valuation,
based upon which we make contributions to the Gratuity Fund. Trustees administer the contributions
made to the Gratuity Fund. The amounts contributed to the Gratuity Fund are invested in specific
securities as mandated by law and generally consist of federal and state government bonds and the
debt instruments of government-owned corporations.
In respect of certain of our other employees, the gratuity benefit is provided through annual
contribution to a fund managed by the Life Insurance Corporation of India (LIC). Under this
scheme, the settlement obligation remains with us, although the LIC administers the fund and
determines the contribution premium required to be paid by us. The net contribution amounts
recognized by us were Rs.24.0 million, Rs.18.0 million and Rs.31.2 million during the years ended
March 31, 2003, 2004 and 2005, respectively.
Superannuation benefits. Apart from being covered under the Gratuity Plan described above, our
senior officers also participate in superannuation, a defined contribution plan administered by the
LIC. We make annual contributions based on a specified percentage of each covered employees
salary. We have no further obligations under the plan beyond our annual contributions. We
contributed Rs.19.4 million, Rs.24.2 million and Rs.27.0 million to the superannuation plan during
the years ended March 31, 2003, 2004 and 2005, respectively.
Provident fund benefits. In addition to the above benefits, all employees receive benefits
from a provident fund, a defined contribution plan. Both the employee and employer each make
monthly contributions to the plan each equal to
63
12% of the covered employees salary. We have no further obligations under the plan beyond our
monthly contributions. We contributed Rs.47.5 million, Rs.58.7 million and Rs.64.2 million to the
provident fund plan during the years ended March 31, 2003, 2004 and 2005, respectively.
6.C. Board practices
Our Articles of Association require us to have a minimum of 3 and a maximum of 20 directors.
As of March 31, 2005, we have 9 directors on our Board, of which 6 are non-full time independent
directors.
The Companies Act, 1956 and our Articles of Association require that at least two-thirds of
our directors be subject to re-election by our shareholders in rotation. At every annual general
meeting, one-third of the directors who are subject to re-election must retire and, if eligible for
re-election, may be reappointed at the annual general meeting. Our full time directors are not
subject to re-election.
The terms of each of our directors and their expiration dates are provided in the table below.
|
|
|
|
|
|
|
|
|
Expiration of Current |
|
|
|
|
Name |
|
Term of Office |
|
Term of Office |
|
Period of Service |
Dr. K. Anji Reddy (1)
|
|
July 13, 2006
|
|
5 years
|
|
21 years |
Mr. Satish Reddy (1)
|
|
September 30, 2007
|
|
5 years
|
|
12 years |
Mr. G. V. Prasad (1)
|
|
January 30, 2006
|
|
5 years
|
|
19 years |
Mr. Anupam Puri (2)
|
|
Retirement by rotation
|
|
Due for retirement by rotation in 2007
|
|
3 years |
Dr. Krishna G. Palepu (2)
|
|
Retirement by rotation
|
|
Due for retirement by rotation in 2005
|
|
3 years |
Mr. P. N. Devarajan (2)
|
|
Retirement by rotation
|
|
Due for retirement by rotation in 2006
|
|
4.5 years |
Dr. Omkar Goswami (2)
|
|
Retirement by rotation
|
|
Due for retirement by rotation in 2006
|
|
4.5 years |
Mr. Ravi Bhoothalingam (2)
|
|
Retirement by rotation
|
|
Due for retirement by rotation in 2005
|
|
4.5 years |
Dr. V. Mohan (2)
|
|
Retirement by rotation
|
|
Due for retirement by rotation in 2006
|
|
9 years |
|
|
|
(1) |
|
Full time director. |
|
(2) |
|
Non-full time independent director. |
The terms of the contracts with our full-time directors are also disclosed to all the
shareholders in the notice of the general meeting. The directors are not eligible for any
termination benefit on the termination of their tenure with us.
Committees of the Board
Committees appointed by the Board focus on specific areas and take decisions within the
authority delegated to them. The Committees also make specific recommendations to the Board on
various matters from time-to-time. All decisions and recommendations of the Committees are placed
before the Board for information or approval. We have seven Board-level Committees:
|
|
|
Audit Committee. |
|
|
|
|
Compensation Committee. |
|
|
|
|
Nomination Committee. |
|
|
|
|
Shareholders Grievance Committee. |
|
|
|
|
Management Committee. |
|
|
|
|
Investment Committee. |
|
|
|
|
Strategy Committee. |
The details of the Audit Committee, Compensation Committee and Nomination Committee are
discussed hereunder.
Audit Committee. Our management is primarily responsible for our internal controls and
financial reporting process. Our statutory auditors are responsible for performing independent
audits of our financial statements in accordance with generally accepted auditing standards and for
issuing reports based on such audits. The Board of Directors has entrusted the Audit Committee to
supervise these processes and thus ensure accurate and timely disclosures that maintain the
transparency, integrity and quality of financial controls and reporting.
64
The Audit Committee consists of the following 5 non-full time independent directors:
|
|
|
Dr. Omkar Goswami (Chairman) |
|
|
|
|
Mr. Anupam Puri |
|
|
|
|
Prof. Krishna G. Palepu |
|
|
|
|
Mr. P. N. Devarajan |
|
|
|
|
Mr. Ravi Bhoothalingam |
Our Company Secretary is the Secretary of the Audit Committee. This Committee met on four
occasions during fiscal 2005. Our statutory auditors were present at all Audit Committee meetings
during the year.
The primary responsibilities of the Audit Committee are to:
|
|
|
Supervise the financial reporting process; |
|
|
|
|
Review the financial results, along with the related public filings, before recommending them to the Board; |
|
|
|
|
Review the adequacy of our internal controls, including the plan, scope and performance
of our internal audit function; |
|
|
|
|
Discuss with management our major policies with respect to risk assessment and risk
management; |
|
|
|
|
Hold discussions with statutory auditors on the nature and scope of audits, and any
views that they have about the financial control and reporting processes; |
|
|
|
|
Ensure compliance with accounting standards, and with listing requirements with respect
to the financial statements; |
|
|
|
|
Recommend the appointment and removal of external auditors and their fees; |
|
|
|
|
Review the independence of our auditors; |
|
|
|
|
Ensure that adequate safeguards have been taken for legal compliance both for us and for
our Indian and foreign subsidiaries; |
|
|
|
|
Review related party transactions; and |
|
|
|
|
Review the functioning of our whistle blower policies and procedures. |
Compensation Committee. The Compensation Committee considers and recommends to the Board the
compensation of the full time directors and executives above Vice-President level, and also reviews
the remuneration package that we offer to different grades/levels of our employees. The
Compensation Committee also administers our Employee Stock Option Scheme.
The Compensation Committee consists of the following five non-full time, independent
directors:
|
|
|
Mr. Ravi Bhoothalingam (Chairman) |
|
|
|
|
Mr. Anupam Puri |
|
|
|
|
Prof. Krishna G. Palepu |
|
|
|
|
Dr. Omkar Goswami |
|
|
|
|
Mr. P. N. Devarajan |
The Executive Vice President and Global Chief of Human Resources is the Secretary of the
Committee. The Compensation Committee met three times during fiscal 2005.
Nomination Committee. The primary function of the Nomination Committee is to assist the
Board of Directors in fulfilling its responsibilities by reviewing and making recommendations to
the Board regarding the Boards composition and structure, establishing criteria for Board
membership and evaluating corporate policies relating to the recruitment of Board members and
establishing, implementing and monitoring policies and processes regarding principles of
corporate governance in order to ensure the Boards compliance with its fiduciary duties.
65
The Nomination Committee consists of the following five non-full time, independent directors:
|
|
|
Mr. Anupam Puri (Chairman) |
|
|
|
|
Prof. Krishna G. Palepu |
|
|
|
|
Dr. Omkar Goswami |
|
|
|
|
Mr. P. N. Devarajan |
|
|
|
|
Mr. Ravi Bhoothalingam |
Our Company Secretary is the Secretary of the Committee. The Nomination Committee met once
during fiscal 2005.
Corporate Governance
We constantly endeavor to improve our corporate governance and disclosure practices. As part
of this process, the following major initiatives were undertaken by us during fiscal 2005:
|
|
|
Separate meetings of small groups of Directors, essentially functioning as informal
special committees, on specific business and control matters. |
|
|
|
|
Separate meetings of independent Directors in executive sessions, without the presence of management. |
|
|
|
|
Representation of independent Directors by nomination of a lead independent Director. |
Companies listed on the New York Stock Exchange (NYSE) must comply with certain standards
regarding corporate governance as codified in Section 303A of the NYSEs Listed Company Manual.
Listed companies that are foreign private issuers (as such term is defined in Rule 3b-4 under the
Exchange Act) are permitted to follow home country practice in lieu of the provisions of this
Section 303A, except that such companies are required to comply with the requirements of Sections
303A.06, 303A.11 and 303A.12(b) and (c), which are as follows:
|
(i) |
|
establish an independent audit committee that has specified responsibilities; |
|
|
(ii) |
|
provide prompt certification by its chief executive officer of any material
non-compliance with any corporate governance rules; |
|
|
(iii) |
|
provide periodic written affirmations to the NYSE with respect to its corporate
governance practices; and |
|
|
(iv) |
|
provide a brief description of significant differences between its corporate governance
practices and those followed by U.S. companies. |
The following table compares our principal corporate governance practices to those required of
U.S. NYSE listed companies.
|
|
|
Standard for U.S. NYSE Listed Companies |
|
Our practice |
Listed companies must have a majority of independent
directors, as defined by the NYSE.
|
|
We comply with this standard. Six of
our nine Directors are independent
directors, as defined by the NYSE. |
|
|
|
The non-management directors of each listed company must
meet at regularly scheduled executive sessions without
management.
|
|
We comply with this standard. Our
non-management directors meet
periodically without management
directors in scheduled executive
sessions. |
|
|
|
Listed companies must have a nominating/corporate
governance committee composed entirely of independent
directors. The nominating/corporate governance committee
must have a written charter that addresses the
committees purpose and responsibilities, subject to the
minimum purpose and responsibilities established by the
NYSE, and an annual evaluation of the committee.
|
|
We have a Nomination Committee
composed entirely of independent
directors which meets these
requirements. The committee has a
written charter that meets these
requirements. We do not have a
practice of evaluating the
performance of the Nomination
Committee. |
Listed companies must have a compensation committee
composed entirely of independent directors. The
compensation committee must have a written charter that
addresses the committees purpose
|
|
We have a Compensation Committee
composed entirely of independent
directors which meets these
requirements. The committee has a
written charter |
66
|
|
|
Standard for U.S. NYSE Listed Companies |
|
Our practice |
and responsibilities,
subject to the minimum purpose and responsibilities
established by the NYSE, and an annual evaluation of the
committee.
|
|
that meets these
requirements. We do not have a
practice of evaluating the
performance of Compensation Committee |
|
|
|
Listed companies must have an audit committee that
satisfies the requirements of Rule 10A-3 under the
Exchange Act.
|
|
Our Audit Committee satisfies the
requirements of Rule 10A-3 under the
Exchange Act. |
|
|
|
The audit committee must have a minimum of three members
all being independent directors.
The audit committee must have a written charter that
addresses the committees purpose and responsibilities,
subject to the minimum purpose and responsibilities
established by the NYSE, and an annual evaluation of the
committee.
|
|
We have an audit committee composed
of five members, all being
independent directors. The committee
has a written charter that meets
these requirements. We also have an
internal audit function. We do not
have a practice of evaluating the
performance of our Audit Committee |
|
|
|
Each listed company must have an internal audit function. |
|
|
|
|
|
Shareholders must be given the opportunity to vote on
all equity-compensation plans and material revisions
thereto, with limited exceptions.
|
|
We comply with this standard. Our
Employee Stock Option Plan was
approved by our shareholders. |
|
|
|
Listed companies must adopt and disclose corporate
governance guidelines.
|
|
We have not adopted corporate
governance guidelines. |
|
|
|
All listed companies, U.S. and foreign, must adopt and
disclose a code of business conduct and ethics for
directors, officers and employees, and promptly disclose
any waivers of the code for directors or executive
officers.
|
|
We comply with this standard. More
details on our Code of Business
Conduct and Ethics are given under
Item 16.B. |
|
|
|
Listed foreign private issuers must disclose any
significant ways in which their corporate governance
practices differ from those followed by domestic
companies under NYSE listing standards.
|
|
This requirement is being addressed
by way of this table. |
|
|
|
Each listed company CEO must certify to the NYSE each
year that he or she is not aware of any violation by the
company of NYSE corporate governance listing standards,
qualifying the certification to the extent necessary.
|
|
No such certification has been issued. |
|
|
|
Each listed company CEO must promptly notify the NYSE in
writing after any executive officer of the listed
company becomes aware of any material non-compliance
with any applicable provisions of this Section 303A.
|
|
There are no such instances. |
|
|
|
Each listed company must submit an executed Written
Affirmation annually to the NYSE. In addition, each
listed company must submit an interim Written
Affirmation each time a change occurs to the board or
any of the committees subject to Section 303A. The
annual and interim Written Affirmations must be in the
form specified by the NYSE.
|
|
As a foreign private issuer, we are
not required to submit our initial
Annual Written Affirmation until 30
days after July 31, 2005. |
67
6.D. Employees
The following table sets forth the number of our employees during fiscal 2003, 2004 and 2005.
For
the Fiscal Year Ended March 31, 2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
North America |
|
Europe |
|
Rest of the World |
|
Total |
Manufacturing(1) |
|
|
|
|
|
|
45 |
|
|
|
2,517 |
|
|
|
2,562 |
|
Sales and Marketing(2) |
|
|
21 |
|
|
|
4 |
|
|
|
1,833 |
|
|
|
1,858 |
|
Research & Development |
|
|
15 |
|
|
|
2 |
|
|
|
1,106 |
|
|
|
1,123 |
|
Others(3) |
|
|
45 |
|
|
|
13 |
|
|
|
534 |
|
|
|
592 |
|
|
Total |
|
|
81 |
|
|
|
64 |
|
|
|
5,990 |
|
|
|
6,135 |
|
|
For
the Fiscal Year Ended March 31, 2004
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
North America |
|
Europe |
|
Rest of the World |
|
Total |
Manufacturing(1) |
|
|
|
|
|
|
52 |
|
|
|
2,270 |
|
|
|
2,322 |
|
Sales and Marketing(2) |
|
|
25 |
|
|
|
4 |
|
|
|
2,193 |
|
|
|
2,222 |
|
Research & Development |
|
|
17 |
|
|
|
|
|
|
|
876 |
|
|
|
893 |
|
Others(3) |
|
|
33 |
|
|
|
3 |
|
|
|
682 |
|
|
|
718 |
|
|
Total |
|
|
75 |
|
|
|
59 |
|
|
|
6,021 |
|
|
|
6,155 |
|
|
For
the Fiscal Year Ended March 31, 2003
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
North America |
|
Europe |
|
Rest of the World |
|
Total |
Manufacturing(1) |
|
|
|
|
|
|
48 |
|
|
|
2,206 |
|
|
|
2,254 |
|
Sales and Marketing(2) |
|
|
22 |
|
|
|
3 |
|
|
|
2,079 |
|
|
|
2,104 |
|
Research & Development |
|
|
16 |
|
|
|
|
|
|
|
817 |
|
|
|
833 |
|
Others(3) |
|
|
29 |
|
|
|
3 |
|
|
|
629 |
|
|
|
661 |
|
|
Total |
|
|
67 |
|
|
|
54 |
|
|
|
5,731 |
|
|
|
5,852 |
|
|
(1) |
|
Includes quality, technical services and warehouse. |
|
(2) |
|
Includes business development. |
|
(3) |
|
Includes shared services, corporate business development and the intellectual property management team. |
We have not experienced any material work stoppages in the last three fiscal years and we
consider our relationship with our employees and labor unions to be good. Approximately 13% of our
employees belong to labor unions. We did not experience any strikes at our manufacturing facilities
in fiscal 2005.
68
6.E. Share ownership
The following table sets forth, as of March 31, 2005 for each of our directors and executive
officers, the total number of our equity shares and options owned by them:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% of |
|
|
|
|
|
|
|
|
|
|
No. of shares |
|
outstanding |
|
No. of |
|
Fiscal Year |
|
|
|
|
Name |
|
held(1),(3) |
|
capital |
|
options held |
|
of the Grant |
|
Exercise price |
|
Expiration date |
|
Dr. K. Anji Reddy(2),(4) |
|
|
400,478 |
|
|
|
0.52 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mr. G.V. Prasad(4) |
|
|
686,772 |
|
|
|
0.90 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mr. Satish Reddy(4) |
|
|
597,916 |
|
|
|
0.78 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mr. Anupam Puri |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Prof. Krishna G Palepu |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dr. Omkar Goswami |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mr. P.N. Devarajan |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mr. Ravi Bhoothalingam |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dr. V. Mohan |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mr. V.S. Vasudevan |
|
|
|
|
|
|
|
|
|
|
5,740 |
|
|
|
2003 |
|
|
Rs. |
1,063.02 |
|
|
|
(5 |
) |
|
|
|
|
|
|
|
|
|
|
|
10,000 |
|
|
|
2004 |
|
|
|
883.00 |
|
|
|
(5 |
) |
|
|
|
|
|
|
|
|
|
|
|
10,000 |
|
|
|
2005 |
|
|
|
885.00 |
|
|
|
(5 |
) |
Mr. Abhijit Mukherjee |
|
|
|
|
|
|
|
|
|
|
3,200 |
|
|
|
2005 |
|
|
|
5.00 |
|
|
|
(5 |
) |
Mr. Alan Shephard |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mr. Andrew Miller |
|
|
|
|
|
|
|
|
|
|
30,000 |
|
|
|
2002 |
|
|
|
977.30 |
|
|
|
01.28.2007 |
|
|
|
|
|
|
|
|
|
|
|
|
6,800 |
|
|
|
2005 |
|
|
|
5.00 |
|
|
|
(5 |
) |
Mr. Arun Sawhney |
|
|
|
|
|
|
|
|
|
|
11,880 |
|
|
|
2005 |
|
|
|
5.00 |
|
|
|
(5 |
) |
Mr. Ashwani Kumar Malhotra |
|
|
|
|
|
|
|
|
|
|
7,408 |
|
|
|
2005 |
|
|
|
5.00 |
|
|
|
(5 |
) |
Dr. Dennis Langer |
|
|
|
|
|
|
|
|
|
|
104,000 |
|
|
|
2005 |
|
|
|
5.00 |
|
|
|
(5 |
) |
Mr. Jaspal Singh Bajwa |
|
|
|
|
|
|
|
|
|
|
8,000 |
|
|
|
2005 |
|
|
|
5.00 |
|
|
|
(5 |
) |
Mr. K.B. Sankara Rao |
|
|
23,724 |
|
|
|
|
|
|
|
7,718 |
|
|
|
2005 |
|
|
|
5.00 |
|
|
|
(5 |
) |
Mr. Mark Hartman |
|
|
|
|
|
|
|
|
|
|
60,000 |
|
|
|
2003 |
|
|
|
1,063.02 |
|
|
|
(6 |
) |
|
|
|
|
|
|
|
|
|
|
|
10,000 |
|
|
|
2004 |
|
|
|
883.00 |
|
|
|
(5 |
) |
|
|
|
|
|
|
|
|
|
|
|
6,000 |
|
|
|
2005 |
|
|
|
885.00 |
|
|
|
(5 |
) |
Mr. Osagie O. Imasogie |
|
|
26,872 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dr. R. Rajagopalan |
|
|
|
|
|
|
|
|
|
|
9,680 |
|
|
|
2005 |
|
|
|
5.00 |
|
|
|
(5 |
) |
Mr. Raghu Cidambi |
|
|
|
|
|
|
|
|
|
|
8,000 |
|
|
|
2005 |
|
|
|
5.00 |
|
|
|
(5 |
) |
Mr. Saumen Chakraborty |
|
|
1,000 |
|
|
|
|
|
|
|
7,500 |
|
|
|
2004 |
|
|
|
883.00 |
|
|
|
(5 |
) |
|
|
|
|
|
|
|
|
|
|
|
7,200 |
|
|
|
2005 |
|
|
|
5.00 |
|
|
|
(5 |
) |
Dr. Uday Saxena |
|
|
75,000 |
|
|
|
|
|
|
|
8,000 |
|
|
|
2005 |
|
|
|
5.00 |
|
|
|
(5 |
) |
|
|
|
(1) |
|
Shares held in their individual name only. |
|
(2) |
|
Does not include shares held beneficially. See Item 7.A. for beneficial ownership of shares
by this individual. |
|
(3) |
|
All shares have voting rights. |
|
(4) |
|
Not eligible for grant of Stock Options. |
|
(5) |
|
The expiry period is 5 years from the date of vesting. The options vest each year over a
period of 4 years. |
|
(6) |
|
The expiry period is 5 years from the date of vesting. The options vest in graded
manner over a period of 3 years. |
Employee Stock Incentive Plans
Dr. Reddys Employees Stock Option Plan-2002 (the DRL 2002 Plan): We instituted the DRL 2002
Plan, our employee stock option scheme, in fiscal 2002 for all eligible employees. The shareholders
approved the reservation of 2,295,478 equity shares (being 3% of the outstanding equity shares on
that day) for the purposes of making grants of options under the DRL 2002 Plan. The DRL 2002 Plan
is applicable to our employees and directors and to employees and directors of our subsidiaries.
The DRL 2002 Plan is not applicable to promoter directors, promoter employees and the persons
holding 2% or more of our outstanding share capital.
The Compensation Committee administers the DRL 2002 Plan and determines the employees and
directors eligible for receiving the options, the number of options to be granted, the exercise
price, the vesting period and the exercise period. The vesting period is determined for all options
issued on the date of the grant, with a minimum vesting period of 12 months.
The DRL 2002 Plan was amended on July 28, 2004 at the annual general meeting of shareholders
to provide for stock options grants in two categories:
Category A: 1,721,700 stock options, out of the total of 2,295,478, were reserved for
grant of options having an exercise price equal to the fair market value of the underlying equity
shares on the date of grant; and
69
Category B: 573,778 stock options, out of the total of 2,295,478, were reserved
for grant of options having an exercise price equal to the par value of the underlying equity
shares (i.e., Rs.5 per option).
The fair market value of a share on each grant date falling under Category A above is defined
as a price which is not less than the weighted average closing price for 30 days prior to the grant
in the stock exchange where there is highest trading volume during that period, as may be decided
by the Compensation Committee. Notwithstanding the foregoing, the Compensation Committee may, after
getting the approval of the shareholders in the annual general meeting, grant options with a per
share exercise price other than fair market value and par value of the equity shares.
On January 24, 2005, certain employees surrendered their fair market value options (Category
A) and we issued par value options (Category B) to such employees. This transaction was a
modification of the DRL 2002 Plan and the incremental expenses, being the difference between the
fair value of the Category A options on the date of modification and the fair value of the Category
B options as per the guidance in SFAS 123, has been recognized in the statements of operation over
the vesting period of the Category B options.
Stock option activity under the DRL 2002 Plan in two categories of options (i.e. fair market
value and par value options) is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal
Year Ended March 31, 2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
average |
|
|
|
|
|
|
|
|
|
|
average |
|
remaining |
|
|
Shares arising |
|
Range of exercise |
|
exercise |
|
contractual |
|
|
out of options |
|
prices |
|
price |
|
life (months) |
Outstanding at the beginning of the period |
|
|
543,871 |
|
|
Rs. |
884-1,063.02 |
|
|
|
Rs.995.42 |
|
|
|
56 |
|
Granted during the period |
|
|
423,300 |
|
|
|
883-1,396 |
|
|
|
934.44 |
|
|
|
62 |
|
Expired / forfeited during the period |
|
|
(53,132 |
) |
|
|
883-1,063.02 |
|
|
|
962.54 |
|
|
|
|
|
Exercised during the period |
|
|
(3,001 |
) |
|
|
911-1,063.02 |
|
|
|
1,013.12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at the end of the period |
|
|
911,038 |
|
|
|
883-1,396 |
|
|
|
968.95 |
|
|
|
66 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at the end of the period |
|
|
315,068 |
|
|
Rs. |
884-1,063.02 |
|
|
|
Rs.976.15 |
|
|
|
45 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Category
A Fair Market Value Options |
|
Fiscal
Year Ended March 31, 2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
average |
|
|
|
|
|
|
|
|
|
|
average |
|
remaining |
|
|
Shares arising |
|
Range of exercise |
|
exercise |
|
contractual |
|
|
out of options |
|
prices |
|
price |
|
life (months) |
Outstanding at the beginning of the period |
|
|
911,038 |
|
|
|
Rs.883-1,396 |
|
|
|
Rs.968.95 |
|
|
|
66 |
|
Granted during the period |
|
|
466,500 |
|
|
|
747-885 |
|
|
|
872.82 |
|
|
|
82 |
|
Expired / forfeited during the period |
|
|
(352,657 |
) |
|
|
765-1,063.02 |
|
|
|
918.84 |
|
|
|
|
|
Expired during the period due to surrender |
|
|
(725,931 |
) |
|
|
747-1,396 |
|
|
|
928.07 |
|
|
|
|
|
Exercised during the period |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at the end of the period |
|
|
298,950 |
|
|
|
747-1149 |
|
|
|
977.31 |
|
|
|
50 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at the end of the period |
|
|
188,538 |
|
|
|
Rs.883-1,149 |
|
|
|
Rs.996.54 |
|
|
|
35 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Category
B Par Value Options |
|
Fiscal
Year Ended March 31, 2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
average |
|
|
|
|
|
|
|
|
|
|
average |
|
remaining |
|
|
Shares arising |
|
Range of exercise |
|
exercise |
|
contractual |
|
|
out of options |
|
prices |
|
price |
|
life (months) |
Outstanding at the beginning of the period |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted during the period |
|
|
383,523 |
|
|
|
Rs.5 |
|
|
|
Rs.5 |
|
|
|
84 |
|
Forfeited during the period |
|
|
(3,974 |
) |
|
|
5 |
|
|
|
5 |
|
|
|
|
|
Exercised during the period |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at the end of the period |
|
|
379,549 |
|
|
|
5 |
|
|
|
5 |
|
|
|
84 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at the end of the period |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
70
The weighted average grant date fair value for options granted under the DRL 2002 Plan at
fair market value during the years ended March 31, 2004 and March 31, 2005 was Rs.410.50 and
Rs.377.60. The weighted average grant date fair value for options granted under the DRL 2002 Plan
at par value during the year ended March 31, 2005 was Rs.707.40.
Reddy US Therapeutics, Inc. 2000 Equity Ownership Plan: In fiscal 2001, Reddy US
Therapeutics, Inc. (Reddy US), a consolidated subsidiary, adopted the Reddy US Therapeutics Inc.
2000 Equity Ownership Plan (the US Plan) to provide for issuance of stock options to its
employees and certain related non-employees. When the U.S. Plan was established, Reddy US reserved
500,000 shares of its common stock for issuance under the plan. Under the U.S. Plan, stock options
were granted at a price per share not less than the fair market value of the underlying shares of
common stock on the date of grant. The options were to vest over a period of 4 years from the date
of the grant, with 25% of the options vesting at the end of each year.
In fiscal 2004, we determined that it would be in our interests to terminate the US Plan. We
accomplished this by causing Reddy US to accelerate the vesting period of the options issued under
the US Plan. As a result, all of the Reddy US options were vested and exercised by employees.
Contemporaneous with the acceleration, we granted a put option to the employees to swap the shares
of Reddy US common stock arising out of this acceleration with our ADSs at an agreed ratio of 7 ADS
to every 100 outstanding shares of Reddy US common stock. All the Reddy US option holders
exercised this put option, which resulted in our issuing 20,405 ADS in exchange for all of the
outstanding shares of Reddy US. The transaction was consummated on December 2, 2003 by issuing the
treasury stock acquired during the period. Accordingly, there were no options outstanding under
the US Plan during fiscal 2005.
We have evaluated this transaction and have applied the accounting method described in FASB
Interpretation No. 44 and EITF Issue No. 00-23, Issues Related to the Accounting for Stock
Compensation under APB Opinion No. 25 and FASB Interpretation No. 44, and have determined the
award as a liability. Consequently an amount of Rs.25.6 million has been accounted for as
compensation cost. Further, an amount of Rs.0.2 million, representing the unrecognized
compensation cost, was recognized as a result of this acceleration.
Aurigene Discovery Technologies Limited ESOP Plan 2003. Aurigene Discovery Technologies
Limited (Aurigene), a consolidated subsidiary, adopted the Aurigene Discovery Technologies
Limited Employee Stock Option Plan (the Aurigene Employee Plan) to provide for issuance of stock
options to employees of Aurigene and its subsidiary, Aurigene Discovery Technologies Inc., who have
completed one full year of service with Aurigene and its subsidiary. Aurigene has reserved
4,550,000 of its ordinary shares for issuance under this plan. Under the Aurigene Employee Plan,
stock options may be granted at an exercise price as may be determined by Aurigenes compensation
committee. On August 1, 2003, 200,000 stock options at an exercise price of Rs.10 each were
awarded to the employees of Aurigene and its subsidiary with a vesting period of 3 years (i.e.,
they fully vest on July 31, 2006). As of March 31, 2005, there were 197,178 stock options
outstanding.
71
Aurigene Discovery Technologies Limited, Management Group Stock Grant Plan. In fiscal 2004,
Aurigene adopted the Aurigene Discovery Technologies Limited Management Group Stock Grant Plan (the
Aurigene Management Plan) to provide for issuance of stock options to management employees of
Aurigene and its subsidiary Aurigene Discovery Technologies Inc. Aurigene has reserved 2,950,000
of its ordinary shares for issuance under this plan. Under the Aurigene Management Plan, stock
options may be granted at an exercise price as may be determined by Aurigenes compensation
committee. For fiscal 2004, a total of 783,333 stock options at an exercise price of Rs.10 each
were awarded to the employees of Aurigene on August 1, 2003 and the recipients have a period of 7
years (i.e., until July 31, 2010) to exercise the options. The exercise price is equal to the fair
value of the underlying equity shares as determined by Aurigenes compensation committee. As of
March 31, 2005, there were 100,000 stock options outstanding under the Aurigene Management Plan.
ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS
7.A. Major shareholders
A total of 26.30% of our equity shares is held by the following parties:
|
|
|
Dr. K. Anji Reddy (Chairman), |
|
|
|
|
Mr. G .V. Prasad (Executive Vice Chairman and CEO), |
|
|
|
|
Mr. Satish Reddy (Managing Director and COO), |
|
|
|
|
Mrs. K. Samrajyam, wife of Dr. K. Anji Reddy, and Mrs. G. Anuradha, wife of Mr. G.V.
Prasad (hereafter collectively referred as the Family Members), and |
|
|
|
|
Dr. Reddys Holdings Private Limited (a company in which Dr. K. Anji Reddy owns 40% of
the equity and remainder is owned by Mr. G V Prasad, Mr. Satish Reddy and the Family
Members) |
The following table sets forth information regarding the beneficial ownership of our shares by
the foregoing persons as of March 31, 2005:
|
|
|
|
|
|
|
|
|
Name |
|
Equity Shares |
|
|
Beneficially Owned (1) |
|
|
Number |
|
Percentage |
|
|
of Shares |
|
of Shares |
Dr. K. Anji Reddy(2) |
|
|
18,278,208 |
|
|
|
23.89 |
% |
Mr. G.V. Prasad |
|
|
686,772 |
|
|
|
0.90 |
% |
Mr. Satish Reddy |
|
|
597,916 |
|
|
|
0.78 |
% |
Family Members |
|
|
558,428 |
|
|
|
0.73 |
% |
Subtotal |
|
|
20,121,324 |
|
|
|
26.30 |
% |
|
Others/public float |
|
|
56,397,625 |
|
|
|
73.70 |
% |
|
Total number of shares outstanding |
|
|
76,518,949 |
|
|
|
100.00 |
% |
|
|
|
|
(1) |
|
Beneficial ownership is determined in accordance with rules of the U.S. Securities and
Exchange Commission, which provide that shares are beneficially owned by any person who has or
shares voting or investment power with respect to the shares. All information with respect to the
beneficial ownership of any principal shareholder has been furnished by that shareholder and,
unless otherwise indicated below, we believe that persons named in the table have sole voting and
sole investment power with respect to all shares shown as beneficially owned, subject to community
property laws where applicable. |
|
(2) |
|
Dr. Reddys Holdings Private Limited owns 17,877,730 shares of Dr. Reddys Laboratories
Limited. Dr. K. Anji Reddy owns 40% of Dr. Reddys Holdings Private Limited. The remainder is owned
by Mr. G V Prasad, Mr. Satish Reddy and the Family Members. The entire amount beneficially owned
by Dr. Reddys Holdings Private Limited is included in the amount shown as beneficially owned by
Dr. K. Anji Reddy. |
As otherwise stated above and to the best of our knowledge, we are not owned or
controlled directly or indirectly by any government or by any other corporation or by any other
natural or legal persons. We are not aware of any arrangement, the consummation of which may at a
subsequent date result in a change in our control.
We are required to disclose names and shareholding of the persons who are holding more than 1%
of the outstanding shares of our company to the Stock Exchanges in India. The disclosure is
required to be made on March 31, June 30, September 30 and December 31 every year.
72
The following shareholders hold more than 1% of the equity shares of our company as of June
30, 2005 as compared to the shareholding as of March 31, 2005, March 31, 2004 and March 31, 2003.
|
|
|
|
|
|
|
|
|
|
|
Name |
|
30-June-05 |
|
31-Mar-05 |
|
31-Mar-04 |
|
31-Mar-03 |
|
|
No. of equity |
|
% of equity |
|
No. of equity |
|
% of equity |
|
No. of equity |
|
% of equity |
|
No. of equity |
|
% of equity |
|
|
shares held* |
|
shares held |
|
shares held* |
|
shares held |
|
shares held* |
|
shares held |
|
shares held* |
|
shares held |
Dr. Reddys Holdings Pvt. Limited |
|
|
17,889,030 |
|
|
|
23.37 |
|
|
|
17,877,730 |
|
|
|
23.36 |
|
|
|
17,461,730 |
|
|
|
22.82 |
|
|
|
17,461,730 |
|
|
|
22.82 |
|
Life Insurance Corporation of India |
|
|
7,390,903 |
|
|
|
9.66 |
|
|
|
7,355,048 |
|
|
|
9.61 |
|
|
|
5,295,128 |
|
|
|
6.92 |
|
|
|
5,038,583 |
|
|
|
6.58 |
|
HSBC Global Investment Funds |
|
|
1,569,969 |
|
|
|
2.05 |
|
|
|
1,471,921 |
|
|
|
1.92 |
|
|
|
1,535,700 |
|
|
|
2.01 |
|
|
|
89,931 |
|
|
|
0.12 |
|
J P Morgan
Flemming Assets Management |
|
|
1,211,857 |
|
|
|
1.58 |
|
|
|
435,000 |
|
|
|
0.57 |
|
|
|
244,000 |
|
|
|
0.32 |
|
|
|
|
|
|
|
|
|
FID Funds (Mauritius) Limited |
|
|
1,032,564 |
|
|
|
1.35 |
|
|
|
602,734 |
|
|
|
0.79 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deutsche Securities Mauritius Limited |
|
|
876,779 |
|
|
|
1.15 |
|
|
|
705,390 |
|
|
|
0.92 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Government of Singapore |
|
|
809,491 |
|
|
|
1.06 |
|
|
|
745,465 |
|
|
|
0.97 |
|
|
|
681,457 |
|
|
|
0.89 |
|
|
|
484,777 |
|
|
|
0.63 |
|
|
Note: Does not include ADS holdings
All of our shares carry the same voting rights.
As of March 31, 2005, we have 76,518,949 issued and outstanding equity shares. As of March 31,
2005 there were 69,538 record holders of our equity shares listed and traded on the Indian stock
exchanges. Our American Depositary Shares are listed on the New York Stock Exchange. One ADS
represents one equity share of Rs.5 per value per share. As of March 31, 2005, 26.49% of our issued
and outstanding equity shares were held by ADS holders. On March 31, 2005 we had approximately
12,049 ADS holders on record in the U.S.
7.B. Related party transactions
We have entered into transactions with the following related parties:
|
|
|
Diana Hotels Limited for availing hotel services; |
|
|
|
|
AR Chlorides for availing processing services of raw materials and intermediates; |
|
|
|
|
Dr. Reddys Holdings Limited for purchase and sale of active
pharmaceutical ingredients and intermediates; |
|
|
|
|
Madras Diabetes Research Foundation for undertaking research on our behalf; |
|
|
|
|
Dr. Reddys Heritage Foundation for purchase of services; |
|
|
|
|
SR Enterprises for transportation services; and |
|
|
|
|
Manava Seva Dharma Samvardhani Trust for social contribution to which we have made contribution. |
Our directors have either a significant ownership interest, controlling interest or exercise
significant influence over these entities (significant interest entities). We have also entered
into transactions with our employees and directors and their relatives.
|
|
|
One of our executives and U.S. general counsel, hired on July 15, 2002, is a
shareholder of a law firm that we engage for legal services. Legal fees paid by us
to such law firm were Rs.373,563, Rs.423,137 and Rs.468,758 during the years ended
March 31, 2003, 2004 and 2005 respectively. |
The following is a summary of significant related party transactions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal
Year Ended March 31, |
|
|
2003 |
|
2004 |
|
2005 |
Purchases from: |
|
|
|
|
|
|
|
|
|
|
|
|
Significant interest entities |
|
Rs. |
50,943 |
|
|
|
Rs.59,889 |
|
|
Rs. |
45,239 |
|
Reddy Kunshan |
|
|
|
|
|
|
107,801 |
|
|
|
39,278 |
|
73
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal
Year Ended March 31, |
|
|
2003 |
|
2004 |
|
2005 |
Sales to: |
|
|
|
|
|
|
|
|
|
|
|
|
Significant interest entities |
|
|
763 |
|
|
|
1,185 |
|
|
|
1,055 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Administrative expenses paid to: |
|
|
|
|
|
|
|
|
|
|
|
|
Significant interest entities |
|
|
7,749 |
|
|
|
4,793 |
|
|
|
4,649 |
|
Directors and their relatives |
|
|
16,807 |
|
|
|
16,891 |
|
|
|
17,144 |
|
We have the following amounts due from related parties:
|
|
|
|
|
|
|
|
|
|
|
As of March 31, |
|
|
2004 |
|
2005 |
Directors and their relatives |
|
|
Rs.3,680 |
|
|
|
Rs.3,680 |
|
Employee loans |
|
|
39,776 |
|
|
|
18,199 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Rs.43,456 |
|
|
|
Rs.21,879 |
|
|
|
|
|
|
|
|
|
|
We have the following amounts due to related parties:
|
|
|
|
|
|
|
|
|
|
|
As of March 31, |
|
|
2004 |
|
2005 |
Significant interest entities |
|
|
Rs.14,009 |
|
|
|
Rs.10,996 |
|
Reddy Kunshan |
|
|
12,410 |
|
|
|
5,401 |
|
Interest free deposit from affiliate |
|
|
53,000 |
|
|
|
|
|
Payable towards legal fees |
|
|
121,751 |
|
|
|
123,106 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Rs.201,170 |
|
|
|
Rs.139,503 |
|
|
|
|
|
|
|
|
|
|
As of March 31, 2005, the outstanding amounts of employee loans are given below:
|
|
|
|
|
Repayable in the year ending March 31: |
|
|
|
|
2006 |
|
Rs. |
10,812 |
|
2007 |
|
|
5,316 |
|
2008 |
|
|
1,819 |
|
2009 |
|
|
226 |
|
2010 |
|
|
26 |
|
Thereafter |
|
|
|
|
|
|
|
|
|
|
|
Rs. |
18,199 |
|
|
|
|
|
|
7.C. Interests of experts and counsel
Not applicable.
ITEM 8. FINANCIAL INFORMATION
8.A. Consolidated statements and other financial information
The following financial statements and auditors report for fiscal 2005 are incorporated herein
by reference and are included in Item 18 of this report on Form 20-F:
|
|
|
Report of Independent Registered Public Accounting Firm. |
|
|
|
|
Consolidated Balance Sheets as of March 31, 2004 and 2005. |
|
|
|
|
Consolidated Statements of Income for the years ended March 31, 2003, 2004 and 2005. |
|
|
|
|
Consolidated Statements of Stockholders Equity and Comprehensive Income for the years
ended March 31, 2003, 2004 and 2005. |
|
|
|
|
Consolidated Statements of Cash Flow for the years ended March 31, 2003, 2004 and 2005. |
|
|
|
|
Notes to the Consolidated Financial Statements. |
Amount of Export Sales
74
For the fiscal year ended March 31, 2005, our export revenues were Rs.12,778.9 million,
contributing 65.6% to our total revenues.
Legal Proceedings
Patent Challenges
At times, following our determination that an innovators patent is invalid or not infringed
by our products, we seek to develop generic products for sale prior to patent expiration in various
countries. In the United States, to obtain generic approval for a product prior to the expiration
of the innovators patent, we challenge the innovators patent. As a result of invoking such patent
challenge procedures, in the ordinary course of business we often become a party to, and expect to
continue to be involved in, patent litigation regarding the validity or infringement of innovator
patents. In addition, in the ordinary course of business we are, and expect to continue to be, a
party to patent litigation involving the extent to which manufacturing process techniques may
infringe on innovator or third party process patents.
Environmental Litigation
The Indian Council for Environmental Legal Action (the Council) filed a writ in 1989 under
Article 32 of the Constitution of India against the Union of India and others in the Supreme Court
of India for the safety of people living in the Patancheru and Bollarum areas of the Medak district
of Andhra Pradesh, India. The Council seeks to provide clean drinking water to people living in
these areas whose water supplies are affected by chemical industrial pollution. The Council is
asking for relief in the nature of an order directing the Union and the State Government to avert
pollution and compensate those affected by it.
We believe it will be some time from now before there is a resolution of this environmental
litigation because there are 62 industries operating in Bollarum, 32 of which discharge industrial
effluent into the Nakka River. We believe that we have maintained our effluent treatment plants and
treated the effluents well within the limits prescribed by the environmental authorities and have
also made payment towards the compensation to be paid to farmers in this region. However, if
companies that are subject to this litigation are found not to be compliant, then all companies
affected by the litigation may be required to cease operations. This may affect our operations
until judicial relief from a higher court is obtained from such an order. We will continue to
upgrade our effluent treatment plants in accordance with the directives issued by the Pollution
Control Board and comply with the directions given by the Andhra Pradesh High Court (the High
Court) in this regard.
The total compensation that we have paid to date at the direction of the High Court is Rs.2.0
million. Such payments were made during fiscal years 1993, 1994, 1996, 1997, 2001 and 2004 and have
been charged to the income statement in the year of payment. Such payments were made in full to the
extent demanded from us by the High Court. Although the matter is still pending before the courts,
in consultation with our external legal counsel in India, we consider the possibility of additional
liability to be remote. We cannot estimate our liability in the event that we are unsuccessful in
this case. Even if we are discharged from this litigation, the amount already paid to the High
Court will not be returned to us.
Norfloxacin litigation
We manufacture and distribute norfloxacin, a formulations product. Under the Drugs (Prices
Control) Order, 1995 (DPCO), the government of India has the authority to designate a
pharmaceutical product as a specified product and to fix the maximum selling price for such
product. In 1995, the government of India issued a notification and designated norfloxacin as a
specified product and fixed the maximum selling price.
In 1996, we filed a writ petition in the Honorable High Court of Andhra Pradesh, Hyderabad
(the High Court), against this notification on the ground that the government of India failed to
comply with the rules of the DPCO. In 1996, the High Court granted an interim order in our favor.
In April 2004, the High Court issued an order dismissing the writ petition. Thereafter, we filed a
review petition in the High Court, which was dismissed in October 2004. Subsequently, we appealed
to the Supreme Court of India, New Delhi (the Supreme Court) by filing a Special Leave Petition.
The appeal is currently pending with the Supreme Court. However, in March 2005, we received a
notice from the government of India demanding the recovery of the price we charged for norfloxacin
in excess of the maximum selling price fixed by the
75
government of India including interest thereon. As the matter is pending before the Supreme
Court, we are of the opinion that the notice received from the government of India cannot be
construed as a final demand, hence no payment has been made in respect of this notice, although we
have made a provision for the required amount in our books of accounts in fiscal 2004. As of March
31, 2005, we have provided an amount of Rs.183.6 million representing the excess of the actual
selling price over the maximum selling price fixed by the Indian government.
In the event that we are unsuccessful in the litigation in the Supreme Court, we will be
required to remit the sale proceeds in excess of the maximum selling price to the Indian government
and penalties or interest, if any, the amounts of which are not readily ascertainable.
Sale of OOO JV Reddy Biomed Limited
In October 2004, we signed an agreement to sell our equity shares in OOO JV Reddy Biomed
Limited, a Russian company, to KT&T, a Russian company, for a total consideration of U.S $5
million. Under the terms of the agreement, the transfer of shares is to be completed by September
30, 2005. However, we were subsequently informed that a Moscow court has issued an order of
injunction halting the transfer of shares. We are in the process of initiating an appeal against
the Moscow Court decision. If we are unsuccessful in defending our right to transfer the shares,
we may not be in a position to effect the transfer and complete the sale. We fully provided for our
initial investment of U.S $1.93 million in OOO JV Reddy Biomed Limited in 1997. Pending resolution
of the dispute, the amount received from KT&T has been treated as an advance in the consolidated
financial statements.
Others
Additionally, the Company is involved in other lawsuits, claims, investigations and
proceedings, including patent and commercial matters, which arise in the ordinary course of
business. However, there are no such matters pending that the Company expects to be material in
relation to its business.
Dividend Policy
In the fiscal years ended March 31, 2003, 2004 and 2005, our shareholders declared cash
dividends of Rs.5.0, Rs.5.0 and Rs.5.0, respectively, per equity share. Every year our Board of
Directors recommends the amount of dividends to be paid to shareholders, if any, based upon
conditions then existing, including our earnings, financial condition, capital requirements and
other factors.
Holders of ADSs will be entitled to receive dividends payable on equity shares represented by
such ADSs. Cash dividends on equity shares represented by ADSs are paid to the Depositary in Indian
rupees and are converted by the Depositary into U.S. Dollars and distributed, net of depositary
fees, taxes, if any, and expenses, to the holders of such ADSs.
8.B. Significant changes
In April 2005, the United States District Court for the Southern District of Indiana issued an
opinion following the completion of a trial on Eli Lillys U.S. Patent No. 5,229,382 relating to
Zyprexa(R) and found the patent to be valid. The court decision arises from a May 2001 suit filed
by Eli Lilly against us alleging patent infringement on their 382 compound patent listed on the
Orange Book. The trial was completed in April 2004. We have filed an appeal of the District Courts
decision with the United States Court of Appeals for the Federal Circuit.
ITEM 9. THE OFFER AND LISTING
9.A. Offer and listing details
Information Regarding Price History
The following tables set forth the price history for our shares on The Stock Exchange, Mumbai,
(BSE) and for our ADSs on the New York Stock Exchange (NYSE).
76
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BSE |
|
NYSE |
|
|
Price Per Equity Share |
|
Price Per ADS |
Fiscal Year |
|
|
|
|
|
|
|
|
Ended March 31, |
|
High (Rs.) |
|
Low (Rs.) |
|
High ($) |
|
Low ($) |
2005 |
|
|
1,002.90 |
|
|
|
652.50 |
|
|
|
24.80 |
|
|
|
15.05 |
|
2004 |
|
|
1,470.00 |
|
|
|
808.00 |
|
|
|
33.05 |
|
|
|
17.58 |
|
2003 |
|
|
1,149.90 |
|
|
|
675.00 |
|
|
|
24.00 |
|
|
|
13.30 |
|
2002 |
|
|
1,120.00 |
|
|
|
432.00 |
(1) |
|
|
25.64 |
|
|
|
10.04 |
|
2001 |
|
|
813.50 |
(1) |
|
|
536.90 |
(1) |
|
|
|
|
|
|
|
(2) |
|
|
|
(1) |
|
Stock prices per share have been restated to reflect a 2 for 1 stock split effective on
October 25, 2001. |
|
(2) |
|
ADSs listed on April 11, 2001. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BSE |
|
NYSE |
|
|
Price Per Equity Share |
|
Price Per ADS |
Quarter Ended |
|
High (Rs.) |
|
Low (Rs.) |
|
High ($) |
|
Low ($) |
September 30, 2003 |
|
|
1,225.00 |
|
|
|
994.00 |
|
|
|
27.90 |
|
|
|
21.85 |
|
December 31, 2003 |
|
|
1,470.00 |
|
|
|
1,045.00 |
|
|
|
32.32 |
|
|
|
23.14 |
|
March 31, 2004 |
|
|
1,469.80 |
|
|
|
959.15 |
|
|
|
33.05 |
|
|
|
23.02 |
|
June 30, 2004 |
|
|
1,002.90 |
|
|
|
692.00 |
|
|
|
24.80 |
|
|
|
16.73 |
|
September 30, 2004 |
|
|
795.00 |
|
|
|
652.50 |
|
|
|
17.74 |
|
|
|
15.05 |
|
December 31, 2004 |
|
|
879.00 |
|
|
|
703.00 |
|
|
|
19.90 |
|
|
|
16.18 |
|
March 31, 2005 |
|
|
890.00 |
|
|
|
690.00 |
|
|
|
19.89 |
|
|
|
16.56 |
|
June 30, 2005 |
|
|
762.00 |
|
|
|
613.00 |
|
|
|
17.59 |
|
|
|
14.91 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BSE |
|
NYSE |
|
|
Price Per Equity Share |
|
Price Per ADS |
Month Ended |
|
High (Rs.) |
|
Low (Rs.) |
|
High ($) |
|
Low ($) |
February 25, 2005 |
|
|
759.00 |
|
|
|
690.00 |
|
|
|
18.06 |
|
|
|
16.56 |
|
March 31, 2005 |
|
|
779.90 |
|
|
|
715.00 |
|
|
|
17.75 |
|
|
|
16.74 |
|
April 30, 2005 |
|
|
758.90 |
|
|
|
634.90 |
|
|
|
17.59 |
|
|
|
15.11 |
|
May 31, 2005 |
|
|
730.00 |
|
|
|
613.00 |
|
|
|
16.35 |
|
|
|
14.91 |
|
June 30, 2005 |
|
|
762.00 |
|
|
|
703.00 |
|
|
|
17.00 |
|
|
|
16.00 |
|
July 31, 2005 |
|
|
842.75 |
|
|
|
725.00 |
|
|
|
19.26 |
|
|
|
17.00 |
|
|
Source: www.bseindia.com and www.adr.com, respectively.
9.B. Plan of distribution
Not applicable.
9.C. Markets
Markets on Which Our Shares Trade
Our equity shares are traded on The Stock Exchange, Mumbai (BSE) and National Stock Exchange
Limited (NSE), or collectively, the Indian Stock Exchanges. Our American Depositary Shares (or
ADSs), as evidenced by American Depositary Receipts (or ADRs), are traded in the U.S. on the
New York Stock Exchange (NYSE), under the ticker symbol RDY. Each ADS represents one equity
share. Our ADSs began trading on the NYSE on April 11, 2001. Our shareholders approved the
delisting of our shares from the Hyderabad Stock Exchange Limited, The Stock Exchange, Ahmedabad,
The Madras Stock Exchange Limited, and The Calcutta Stock Exchange Association Limited at the
general body meeting held on August 25, 2003. We have already received the delisting approval
letters from these stock exchanges.
9.D. Selling shareholders
Not applicable.
9.E. Dilution
77
Not applicable.
9.F. Expenses of the issue
Not applicable.
ITEM 10. ADDITIONAL INFORMATION
10.A. Share capital
Not applicable.
10.B. Memorandum and articles of association
Dr. Reddys Laboratories Limited was incorporated under the Indian Companies Act, 1956. We are
registered with the Registrar of Companies, Andhra Pradesh, and Hyderabad, India as Company No.
01-4507. Our registered office is located at 7-1-27, Ameerpet, Hyderabad 500 016, India and the
telephone number of our registered office is +91-40-23731946. The summary of our Articles of
Association and Memorandum of Association that is included in our registration statement on Form
F-1 filed with the U.S. Securities and Exchange Commissions (the SEC) on April 11, 2001,
together with copies of the Articles of Association and Memorandum of Association that are included
in our registration statement on Form F-1, are incorporated herein by reference.
The Memorandum and Articles of Association were amended at the 17th Annual General
Meeting held on September 24, 2001, 18th Annual General Meeting held on August 26, 2002
and 20th Annual General Meeting held on July 28, 2004. A full description of these
amendments was given in the Form 20-F filed with the SEC on September 30, 2003 and September 30,
2004, which description is incorporated herein by reference.
10.C. Material contracts
There are no material contracts, other than contracts entered into in the ordinary course of
business, to which we or any of our direct and indirect subsidiaries is party, for the two years
immediately preceding the date of this Form 20-F.
10.D. Exchange controls
Foreign investment in Indian securities, whether in the form of foreign direct investment or
in the form of portfolio investment, is governed by the Foreign Exchange Management Act, 1999
(FEMA). Set forth below is a summary of the restrictions on transfers applicable to both foreign
direct investments and portfolio investments, including the requirements under Indian law
applicable to the issuance and transfer of ADSs.
Foreign Direct Investment
The Foreign Direct Investment Policy under the Reserve Bank of Indias (RBI) Automatic Route
enables Indian companies (other than those specifically excluded in the scheme) to issue shares to
persons who reside outside of India without prior permission from the RBI, except in cases where
there are ceilings of investments in certain industry sectors and subject to certain conditions.
The Department of Industrial Policy and Promotion, a part of the Ministry of Industry, issued
detailed guidelines in January 1997 for consideration of foreign direct investment proposals by the
Foreign Investment Promotion Board (the Guidelines). The basic objective of the Guidelines is to
improve the transparency and objectivity of the Foreign Investment Promotion Boards consideration
of proposals. However, since these are administrative guidelines and have not been codified as
either law or regulations, they are not legally binding with respect to any recommendation made by
the Foreign Investment Promotion Board or with respect to any decision taken by the Government of
India in cases involving foreign direct investment.
Under the Guidelines, sector specific guidelines for foreign direct investment and the levels
of permitted equity participation have been established. In February 2000, the Department of
Industrial Policy and Promotion issued a notification that foreign ownership of up to 50%, 51%, 74%
or 100%, depending on the category of industry, would be allowed without prior permission of the
Foreign Investment Promotion Board and, in certain cases, without prior permission of the RBI. Over
a period of time, the government of India has relaxed the restrictions on foreign investment.
78
In May 1994, the Government of India announced that purchases by foreign investors of ADSs, as
evidenced by ADRs, and foreign currency convertible bonds of Indian companies would be treated as
direct foreign investment in the equity issued by Indian companies for such offerings. Therefore,
offerings that involve the issuance of equity that results in Foreign Direct Investors holding more
than the stipulated percentage of direct foreign investments (which depends on the category of
industry) would require approval from the Foreign Investment Promotion Board.
In addition, offerings by Indian companies of any such securities to foreign investors require
Foreign Investment Promotion Board approval, whether or not the stipulated percentage limit would
be reached if the proceeds will be used for investment in specified industries.
For investments in the pharmaceutical sector, the Foreign Direct Investment limit is 100%.
Thus, foreign ownership of up to 100% of our equity shares would be allowed without prior
permission of the Foreign Investment Promotion Board and, in certain cases, without prior
permission of the RBI.
Portfolio Investment Scheme
Investments by persons of Indian nationality or origin residing outside of India (also known
as non-resident Indians or NRIs), or overseas corporate bodies (OCBs) or registered Foreign
Institutional Investors (FIIs) made through a stock exchange are known as portfolio investments
(Portfolio Investments).
Portfolio Investments by NRIs and OCBs
A variety of methods for investing in shares of Indian companies are available to NRIs and to
OCBs. These methods allow non-resident Indians and overseas corporate bodies to make portfolio
investments in existing shares and other securities of Indian companies on a basis not generally
available to other foreign investors.
Overseas corporate bodies controlled by NRIs or OCBs were previously permitted to invest on
favorable terms under the RBIs Portfolio Investment Scheme. The RBI no longer recognizes OCBs as
an eligible class of investment vehicle under various circumstances under the RBIs foreign
exchange regulations.
Portfolio Investments by FIIs
In September 1992, the government of India issued guidelines that enable FIIs, including
institutions such as pension funds, investment trusts, asset management companies, nominee
companies and incorporated/institutional portfolio managers, to invest in all the securities traded
on the primary and secondary markets in India. Under the guidelines, FIIs are required to obtain an
initial registration from the Securities and Exchange Board of India (SEBI), and a general
permission from the RBI to engage in transactions regulated under the Foreign Exchange Management
Act. FIIs must also comply with the provisions of the SEBI Foreign Institutional Investors
Regulations, 1995. When it receives the initial registration, the FII also obtains general
permission from the RBI to engage in transactions regulated under the Foreign Exchange Management
Act. Together, the initial registration and the RBIs general permission enable the registered FII
to: (i) buy (subject to the ownership restrictions discussed below) and sell unrestricted
securities issued by Indian companies; (ii) realize capital gains on investments made through the
initial amount invested in India; (iii) participate in rights offerings for shares; (iv) appoint a
domestic custodian for custody of investments held; and (v) repatriate the capital, capital gains,
dividends, interest income and any other compensation received pursuant to rights offerings of
shares. The current policy with respect to purchase or sale of securities of an Indian company by
an FII is in Schedule 2 and Regulation 5(2) of the Foreign Exchange Management (Transfer or Issue
of Securities by a Person Resident Outside India) Regulations, 2000.
Ownership restrictions
The SEBI and the RBI regulations restrict portfolio investments in Indian companies by foreign
institutional investors, non-resident Indians and overseas corporate bodies, all of which we refer
to as foreign portfolio investors. Under current Indian law, foreign institutional investors in
the aggregate may hold not more than 24.0% of the equity shares of an Indian company, and
non-resident Indians and overseas corporate bodies in the aggregate may hold not more than 10.0% of
the shares of an Indian company through portfolio investments. The 24.0% limit referred to above
may be increased to 49.0% if the shareholders of the company pass a special resolution to that
effect. The 10.0% limit referred to above may be increased to 24.0% if the shareholders of the
company pass a special resolution to that effect. No single foreign
79
institutional investor may hold more than 10.0% of the shares of an Indian company and no
single non-resident Indian or overseas corporate body may hold more than 5.0% of the shares of an
Indian company.
In our case, our shareholders have passed a resolution enhancing the limits of portfolio
investment by foreign institutional investors in the aggregate to 49%. Non-resident Indians and
overseas corporate bodies in the aggregate may hold not more than 10.0% of our equity shares
through portfolio investments.
Under the Securities and Exchange Board of India (Substantial Acquisition of Shares and
Takeovers) Regulations, 1997 (the Takeover Code), upon the acquisition of more than 5%, 10%, 14%,
54% or 74% of the outstanding shares or voting rights of a publicly-listed Indian company, the
acquirer is required to disclose the aggregate of his shareholding or voting rights in that target
company to such company. The target company and the said acquirer are required to notify all the
stock exchanges on which the shares of such company are listed. For these purposes, an acquirer
means any person or entity who, directly or indirectly, either alone or acting in concert with any
other person or entity, acquires or agrees to acquire shares or voting rights in, or control over,
a target company.
A person or entity who holds more than 15% of the shares or voting rights in any company is
required to make an annual disclosure of his, her or its holdings to that company, which in turn is
required to disclose the same to each of the stock exchanges on which the companys shares are
listed. A holder of our ADSs would be subject to these notification requirements.
Upon the acquisition of 15% or more of such shares or voting rights, or a change in
control of the company, the acquirer is required to make a public announcement offering to purchase
from the other shareholders at least a further 20% of all the outstanding shares of the company at
a minimum offer price determined pursuant to the Takeover Code. If an acquirer holding more than
15% but less than 55% of shares acquires 5% or more shares during a fiscal year, the acquirer is
required to make a public announcement offering to purchase from the other shareholders at least
20% of all the outstanding shares of the company at a minimum offer price determined pursuant to
the Takeover Code. Any further acquisition of outstanding shares or voting rights of a publicly
listed company by an acquirer who holds more than 55% but less than 75% of shares or voting rights
also requires the making of an open offer to acquire such number of shares as would not result in
the public shareholding being reduced to below the minimum specified in the listing agreement.
Where the public shareholding in the target company may be reduced to a level below the limit
specified in the listing agreement the acquirer may acquire such shares or voting rights only in
accordance with guidelines or regulations regarding delisting of securities specified by SEBI. In
addition, no acquirer may acquire more than 55% of the outstanding shares or voting rights of a
publicly listed company through market purchases or preferential allotments. Any such acquisition
beyond 55% is required to be divested within one year in a manner specified in the Takeover Code.
Since we are a listed company in India, the provisions of the Takeover Code will apply to us
and to any person acquiring our equity shares or voting rights in our company. However, the
Takeover Code provides for a specific exemption from this provision to a holder of ADSs. This
exemption will apply to a holder of ADSs only once he or she converts the ADSs into the underlying
equity shares.
We have entered into listing agreements with each of the Indian stock exchanges on which our
equity shares are listed. Each of the listing agreements provides that if a person or entity
acquires or agrees to acquire 5% or more of the voting rights of our equity shares, the purchaser
and we must, in accordance with the provisions of the Takeover Code, report its holding to us and
the relevant stock exchanges. The listing agreements also provide that if any person or entity
acquires or agrees to acquire our equity shares exceeding 15% of voting rights in our company or if
any person or entity who holds a number of our equity shares which in the aggregate carry less than
15% of the voting rights seeks to acquire our equity shares exceeding 15% of voting rights in our
company, then the acquirer/ purchaser must, in accordance with the provisions of the Takeover Code,
before acquiring such equity shares, make an offer on a uniform basis to all of our remaining
shareholders to acquire equity shares that have at least an additional 20% of the voting rights of
our total outstanding equity shares at a prescribed price.
Although the provisions of the listing agreements entered into between us and the Indian stock
exchanges on which our equity shares are listed will not apply to equity shares represented by
ADSs, holders of ADSs may be required to comply with such notification and disclosure obligations
pursuant to the provisions of the Deposit Agreement to be entered into by such holders, our company
and a depositary.
Subsequent Transfer of shares
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A person resident outside India holding the shares or debentures of an Indian company may
transfer the shares or debentures so held by him, in compliance with the conditions specified in
the relevant Schedule of Foreign Exchange Management (Transfer or Issue of Security by a Person
Resident outside India) Regulations, 2003.
(i) A person resident outside India, not being a non-resident Indian (NRI) or an overseas
corporate body (OCB), may transfer by way of sale or gift the shares or convertible debentures held
by him or it to any person resident outside India;
(ii) A non-resident Indian or an overseas corporate body may transfer by way of sale or gift,
the shares or convertible debentures held by him or it to another non-resident Indian or overseas
corporate body only;
Provided that the person to whom the shares are being transferred, in terms of clause (i) and
(ii), has obtained prior permission of Central Government to acquire the shares if he has previous
venture or tie up in India through investment in shares or debentures or a technical collaboration
or a trade mark agreement or investment by whatever name called in the same field or allied field
in which the Indian company whose shares are being transferred is engaged.
Provided further that the restriction in clauses (i) and (ii) shall not apply to the transfer
of shares to international financial institutions such as Asian Development Bank(ADB),
International Finance Corporation (IFC), Commonwealth Development Corporation(CDC), Deutsche
Entwicklungs Gescelscchaft (DEG) and transfer of shares of an Indian company engaged in Information
Technology sector.
(iii) A person resident outside India holding the shares or convertible debentures of an
Indian company in accordance with the said Regulations,
(a) may transfer the same to a person resident in India by way of gift;
(b) may sell the same on a recognized Stock Exchange in India through a registered broker
Restrictions for subsequent transfers of shares of Indian companies between residents and
non-residents were relaxed significantly as of October 2004. As a result, for a transfer between a
resident and a non-resident of securities of an Indian company, no prior approval of either the RBI
or the Government of India is required, as long as certain conditions are met.
ADS guidelines
Shares of Indian companies represented by ADSs may be approved for issuance to foreign
investors by the Government of India under the Issue of Foreign Currency Convertible Bonds and
Ordinary Shares (Through Depositary Receipt Mechanism) Scheme, 1993(the 1993 Regulations), as
modified from time to time, promulgated by the Government of India. The 1993 Regulations are in
addition but without prejudice to the other policies or facilities, as described below, relating to
investments in Indian companies by foreign investors. The issuance of ADSs pursuant to the 1993
Regulations also affords to holders of the ADSs the benefits of Section 115AC of the Income Tax
Act, 1961 for purpose of the application of Indian tax laws. In March 2001, the RBI issued a
notification permitting, subject to certain conditions, two-way fungibility of ADSs. This
notification provides that ADSs converted into Indian shares can be converted back into ADSs,
subject to compliance with certain requirements and the limits of sectoral caps.
Fungibility of ADSs
A registered broker in India can purchase shares of an Indian company that has issued ADSs, on
behalf of a person resident outside India, for the purposes of converting the shares into ADSs.
However, such conversion of equity shares into ADSs is possible only if the following conditions
are satisfied:
(i) |
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the shares are purchased on a recognized stock exchange; |
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(ii) |
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the shares are purchased with the permission of the Custodian to the
ADS offering of the Indian company and are deposited with the
Custodian; |
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(iii) |
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the shares purchased for conversion into ADSs do not exceed the
number of shares that were released by the Custodian pursuant to
conversions of ADSs into equity shares under the Depositary
Agreement; and |
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(iv) |
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a non-resident investor, broker, the Custodian and the Depository
comply with the provisions of the Scheme for Issue of Foreign
Currency Convertible Bonds and Ordinary Shares (Through Depository
Receipt Mechanism) Scheme, 1993 and the related guidelines issued by
the Central Government from time to time. |
Transfer of ADSs
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A person resident outside India may transfer ADSs held in Indian companies to another person
resident outside India without any permission. A person resident in India is not permitted to hold
ADSs of an Indian company, except in connection with the exercise of stock options.
Shareholders resident outside India who intend to sell or otherwise transfer equity shares
within India should seek the advice of Indian counsel to understand the requirements applicable at
that time.
The RBI placed various restrictions on the ability of OCBs to make investments in Indian
companies in AP (DIR) Series Circular No. 14 dated September 16, 2003. For further information on
these restrictions, the circular is available on www.rbi.org.in for review.
10.E. Taxation
Indian Taxation
General. The following summary is based on the law and practice of the Indian Income-tax Act,
1961 (the Income-tax Act), including the special tax regime contained in Sections 115AC and
115ACA of the Income-tax Act read with the Issue of Foreign Currency Convertible Bonds and Ordinary
Shares (through Depository Receipt Mechanism) Scheme, 1993 (the Scheme), as amended on January
19, 2000. The Income-tax Act is amended every year by the Finance Act of the relevant year. Some or
all of the tax consequences of Sections 115AC and 115ACA may be amended or changed by future
amendments to the Income-tax Act.
We believe this information is materially complete as of the date hereof. However, this
summary is not intended to constitute a complete analysis of the individual tax consequences to
non-resident holders or employees under Indian law for the acquisition, ownership and sale of ADSs
and equity shares. Each prospective investor should consult tax advisors with respect to taxation
in India or their respective locations on acquisition, ownership or disposing of equity shares or
ADSs.
Residence. For purposes of the Income-tax Act, an individual is considered to be a resident of
India during any fiscal year if he or she is in India in that year for:
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a period or periods of at least 182 days; or |
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at least 60 days and, within the four preceding years has been in
India for a period or periods amounting to at least 365 days. |
The period of 60 days referred to above shall be read as 182 days in case of a citizen of
India or a Person of Indian Origin living outside India who visits India and within the four
preceding years has been in India for a period or periods amounting to 365 days or more.
A company is a resident of India if it is formed or registered in India or the control and the
management of its affairs is situated wholly in India. Individuals and companies that are not
residents of India would be treated as non-residents for purposes of the Income-tax Act.
Taxation of Distributions.
a) As per Section 10(34) of the Income-tax Act, dividends paid by Indian Companies on or after
April 1, 2003 to their shareholders (whether resident in India or not) are not subject to tax in
the hands of the shareholders. However, the Indian company paying the dividend is subject to a
dividend distribution tax at the rate of 14.025%, including applicable surcharges and the special
levy called the education cess, on the total amount it distributes, declares or pays as a
dividend.
b) Any distributions of additional ADSs or equity shares to resident or non-resident holders
will not be subject to Indian tax.
Taxation of Capital Gains. The following is a brief summary of capital gains taxation of
non-resident holders and resident employees relating to the sale of ADSs and equity shares received
upon redemption of ADSs. The relevant
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provisions are contained mainly in sections 10(36), 10(38), 45, 47(viia), 111A, 115AC and
115ACA, of the Income-tax Act, in conjunction with the Scheme. You should consult your own tax
advisor concerning the tax consequences of your particular situation.
A non-resident investor transferring our ADS or equity shares, whether transferred in India or
outside India to a non-resident investor, will not be liable for income taxes arising from capital
gains on such ADS or equity shares under the provisions of the Income-tax Act in certain
circumstances. Equity shares (including equity shares issuable on the conversion of the ADSs) held
by the non-resident investor for a period of more than 12 months are treated as long-term capital
assets. If the equity shares are held for a period of less than 12 months from the date of
conversion of the ADSs, the capital gains arising on the sale thereof is to be treated as
short-term capital gains.
Capital gains are taxed as follows:
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gains from a sale of ADSs outside India by a non-resident to another non-resident are
not taxable in India; |
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long-term capital gains realized by a resident employee from the transfer of the ADSs
will be subject to tax at the rate of 10%, plus the applicable surcharge and education
cess; short-term capital gains on such a transfer will be taxed at graduated rates with a
maximum of 30%, plus the applicable surcharge and education cess. |
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long-term capital gains realized by a non-resident upon the sale of equity shares
obtained from the conversion of ADSs are subject to tax at a rate of 10%, plus the
applicable surcharge and education cess; and short-term capital gains on such transfer will
be taxed at the maximum marginal rate of tax applicable to the seller, plus the applicable
surcharge and education cess, if the sale of such equity shares is settled outside of a
recognized stock exchange in India; |
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long-term capital gain realized by a non-resident upon the sale of equity shares
obtained from the conversion of ADSs is exempt from tax and any short term capital gain is
taxed at 10%, plus the applicable surcharge and education cess, if the sale of such equity
shares is settled on a recognized stock exchange and securities transaction tax (STT) is
paid on such sale. The rate of surcharge is currently 2.5% other than in the case of
individuals whose taxable income is greater than Rs.1,000,000 where the rate of surcharge
is 10%; and |
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short-term capital gains realized upon the sale of equity shares obtained from the
redemption of ADSs will be taxed at variable rates with a maximum of (i) 41.82%, including
the prevailing surcharge and education cess, in case of foreign companies and (ii) 10%, in
the case of resident employees or non-resident individuals. An additional surcharge of 10%
will be charged if the aggregate taxable income exceeds Rs.1,000,000 during the relevant
fiscal year. An education cess of 2% will be charged on tax and surcharge. |
As per Section 10(38) of the Income-tax Act, long term capital gains arising from the transfer
of equity shares on or after October 1, 2004 in a company completed through a recognized stock
exchange in India are exempt from Indian tax.
As per Section 111A of the Income-tax Act, short term capital gains arising from the transfer
of equity shares on or after October 1, 2004 in a company completed through a recognized stock
exchange in India are subject to tax at a rate of 10.2% including education cess but excluding the
applicable surcharge
Purchase or sale of equity shares of a company listed on a recognized stock exchange in India
is subject to a security transaction tax of 0.1% of the transaction value for any delivery based
transaction and 0.02% for any non-delivery based transaction.
The above taxes, except security transaction tax, may be offset by the available provisions of
the Income Tax Act, 1961 in the case of non-residents. The capital gains tax is computed by
applying the appropriate tax rates to the difference between the sale price and the purchase price
of the equity shares or ADSs. Under the Scheme, the purchase price of equity shares in an Indian
listed company received in exchange for ADSs will be the market price of the underlying shares on
the date that the Depositary gives notice to the custodian of the delivery of the equity shares in
exchange for the corresponding ADSs, or the stepped up basis purchase price. The market price
will be the price of the equity shares prevailing on the Stock Exchange, Mumbai or the National
Stock Exchange. There is no corresponding provision under the Income-tax Act in relation to the
stepped up basis for the purchase price of equity shares. However, the tax department in India
has not
83
denied this benefit. In the event that the tax department denies this benefit, the original
purchase price of ADSs would be considered the purchase price for computing the capital gains tax.
According to the Scheme, a non-resident holders holding period for the purposes of
determining the applicable Indian capital gains tax rate relating to equity shares received in
exchange for ADSs commences on the date of the notice of the redemption by the Depositary to the
custodian. However, the Scheme does not address this issue in the case of resident employees, and
it is therefore unclear as to when the holding period for the purposes of determining capital gains
tax commences for such a resident employee.
The Scheme provides that if the equity shares are sold on a recognized stock exchange in India
against payment in Indian rupees, they will no longer be eligible for the preferential tax
treatment.
It is unclear as to whether section 115AC and the Scheme are applicable to a non-resident who
acquires equity shares outside India from a non-resident holder of equity shares after receipt of
the equity shares upon redemption of the ADSs.
It is unclear as to whether capital gains derived from the sale of subscription rights or
other rights by a non-resident holder not entitled to an exemption under a tax treaty will be
subject to Indian capital gains tax. If such subscription rights or other rights are deemed by the
Indian tax authorities to be situated within India, the gains realized on the sale of such
subscription rights or other rights will be subject to Indian taxation. The capital gains realized
on the sale of such subscription rights or other rights, which will generally be in the nature of
short-term capital gains, will be subject to tax
(i) at variable rates with a maximum rate of 41.82%, including the prevailing surcharge and
education cess, in the case of a foreign company and (ii) in the range of 30.6% to 33.66%,
including the applicable surcharge, in the case of resident employees and of non-resident
individuals with taxable income over Rs.250,000.
Withholding Tax on Capital Gains. Any gain realized by a non-resident or resident employee on
the sale of equity shares is subject to Indian capital gains tax, which, in the case of a
non-resident is to be withheld at the source by the buyer. However, as per the provisions of
Section 196D(2) of the Income-tax Act, no withholding tax is required to be deducted from any
income by way of capital gains arising to FIIs (as defined in Section 115AD of the Act) on the
transfer of securities (as defined in Section 115AD of the Act).
Buy-back of Securities. Indian companies are not subject to any tax on the buy-back of their
shares. However, the shareholders are taxed on any resulting gains. We are required to deduct tax
at source according to the capital gains tax liability of a non-resident shareholder.
Stamp Duty and Transfer Tax. Upon issuance of the equity shares underlying our ADSs, we are
required to pay a stamp duty of 0.1% per share of the issue price of the underlying equity shares.
A transfer of ADSs is not subject to Indian stamp duty. A sale of equity shares in physical form by
a non-resident holder is also subject to Indian stamp duty at the rate of 0.25% of the market value
of the equity shares on the trade date, although customarily such tax is borne by the transferee.
Shares must be traded in dematerialized form. The transfer of shares in dematerialized form is
currently not subject to stamp duty.
Wealth Tax. The holding of the ADSs and the holding of underlying equity shares by resident
and non-resident holders will be exempt from Indian wealth tax. Non-resident holders are advised to
consult their own tax advisors regarding this issue.
Gift Tax and Estate Duty. Currently, there are no gift taxes or estate duties. These taxes and
duties could be restored in future. Non-resident holders are advised to consult their own tax
advisors regarding this issue.
Service Tax. Brokerage or commission paid to stock brokers in connection with the sale or
purchase of shares is subject to a service tax of 10.2% plus surcharge. The stock broker is
responsible for collecting the service tax from the shareholder and paying it to the relevant
authority.
United States Federal Taxation
The following is a summary of the material U.S. federal income and estate tax consequences
that may be relevant with respect to the acquisition, ownership and disposition of equity shares or
ADSs and is for general information only. This
84
summary addresses the U.S. federal income and estate tax considerations of holders that are
U.S. holders. U.S. holders are beneficial holders of equity shares or ADSs who are (i) citizens
or residents of the United States, (ii) corporations (or entities treated as corporations for U.S.
federal income tax purposes) created in or under the laws of the United States or any political
subdivision thereof or therein, (iii) estates, the income of which is subject to U.S. federal
income taxation regardless of its source, and (iv) trusts for which a U.S. court exercises primary
supervision and one or more U.S. persons have the authority to control all substantial decisions or
that has a valid election in effect under applicable U.S Treasury Regulations to be treated as a
U.S. person. This summary is limited to U.S. holders who will hold equity shares or ADSs as capital
assets. In addition, this summary is limited to U.S. holders who are not resident in India for
purposes of the Convention between the Government of the United States of America and the
Government of the Republic of India for the Avoidance of Double Taxation and the Prevention of
Fiscal Evasion With Respect to Taxes on Income. If a partnership holds equity shares or ADSs, the
tax treatment of a partner will generally depend upon the status of the partner and upon the
activities of the partnership. If you are a partner of a partnership holding equity shares or ADSs,
you should consult your tax advisor.
This summary does not address tax considerations applicable to holders that may be subject to
special tax rules, such as banks, insurance companies, financial institutions, dealers in
securities or currencies, tax-exempt entities, persons that will hold equity shares or ADSs as a
position in a straddle or as part of a hedging or conversion transaction for tax purposes,
persons that have a functional currency other than the U.S. dollar or holders of 10% or more, by
voting power or value, of the shares of our company. This summary is based on the Internal Revenue
Code of 1986 as amended (the Code) through the date of this Form 20-F, and on the United States
Treasury Regulations in effect or, in some cases, proposed, as of the date of this Form 20-F, as
well as judicial and administrative interpretations thereof available on or before such date, and
is based in part on the assumption that each obligation in the deposit agreement and any related
agreement will be performed in accordance with its terms. All of the foregoing are subject to
change, which change could apply retroactively and could affect the tax consequences described
below.
Each prospective investor should consult tax advisors with respect to taxation on acquisition,
ownership or disposing of equity shares or ADSs.
Ownership of ADSs. For U.S. federal income tax purposes, holders of ADSs will be treated as
the holders of equity shares represented by such ADSs. Exchanges of equity shares for ADSs and ADSs
for equity shares generally will not be subject to U.S. federal income tax.
Dividends. Except for ADSs or equity shares, if any, distributed pro rata to all shareholders
of our company, including holders of ADSs, the gross amount of any distributions of cash or
property with respect to ADSs or equity shares (before reduction for any Indian withholding taxes)
will generally be included in income by a U.S. holder as foreign source dividend income at the time
of receipt, which in the case of a U.S. holder of ADSs generally should be the date of receipt by
the Depositary, to the extent such distributions are made from our current or accumulated earnings
and profits (as determined under U.S. federal income tax principles). Special rules apply,
however, to dividends paid to individuals with respect to taxable years beginning on or before
December 31, 2008. Such dividends are eligible for taxation at the rates generally applicable to
long-term capital gains for individuals (currently at a maximum rate of 15%), provided that the
individual receiving the dividend satisfies certain holding period and other requirements with
respect to the ADSs. Dividends subject to these special rules are not actually treated as capital
gains, however, and thus are not included in the computation of an individuals net capital gain
and generally cannot be used to offset capital losses. However, if we are treated as a passive
foreign investment company, dividends will not be eligible for taxation at rates applicable to
long-term capital gains. See Passive Foreign Investment Company below. U.S. holders are urged
to consult their own tax advisors regarding the U.S. federal income tax rate that will be
applicable to their receipt of any dividend paid with respect to our equity shares or ADSs.
The amount of any distribution of property other than cash will be the propertys fair market
value on the date of the distribution. Any dividend received will not be eligible for the
dividends received deduction generally allowed to corporate U.S. holders. To the extent, if any,
that the amount of any distribution by us exceeds our current and accumulated earnings and profits
as determined under U.S. federal income tax principles, it will be treated, first, as a tax-free
return of the U.S. holders tax basis in the equity shares or ADSs and, thereafter, as capital
gain.
Subject to certain conditions and limitations, any Indian withholding tax imposed upon
distributions paid to a U.S. holder with respect to ADSs or equity shares will be eligible for
credit against the U.S. holders federal income tax liability. Alternatively, a U.S. holder may
claim a deduction for such amount, but only for a year in which a U.S. holder
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does not claim a credit with respect to any foreign income taxes. The overall limitation on
foreign taxes eligible for credit is calculated separately with respect to specific classes of
income. For this purpose, dividends distributed by us with respect to equity shares or ADSs will
generally constitute foreign source passive income (or, in the case of certain holders,
financial services income).
If dividends are paid in Indian rupees, the amount of the dividend distribution included in
the income of a U.S. holder will be in the U.S. dollar value of the payments made in Indian rupees,
determined at a spot exchange rate between Indian rupees and U.S. dollars applicable to the date
such dividend is included in the income of the U.S. holder, regardless of whether the payment is in
fact converted into U.S. dollars. Generally, gain or loss, if any, resulting from currency exchange
fluctuations during the period from the date the dividend is paid to the date such payment is
converted into U.S. dollars will be treated as U.S. source ordinary income or loss.
Sale or Exchange of Equity Shares or ADSs. A U.S. holder generally will recognize gain or loss
on the sale, exchange or other taxable disposition of equity shares or ADSs equal to the difference
between the amount realized on such sale, exchange or other taxable disposition and the U.S.
holders tax basis in the equity shares or ADSs, as the case may be. Such gain or loss will be
capital gain or loss, and will be long-term capital gain or loss if the equity shares or ADSs, as
the case may be, were held for more than one year. Under the special rules, long-term capital gain
rates applicable to individuals have been temporarily reduced, in general, to 15% (with lower rates
applying to taxpayers in the 10% and 15% rate brackets) for taxable years beginning on or before
December 31, 2008. Gain or loss, if any, recognized by a U.S. holder generally will be treated as
U.S. source passive income or loss for U.S. foreign tax credit purposes. Capital gains realized by
a U.S. holder upon the sale of equity shares (but not ADSs) may be subject to certain tax in India.
See Taxation Indian Taxation Taxation of Capital Gains. Due to limitations on foreign tax
credits, however, a U.S. holder may not be able to utilize any such taxes as a credit against the
U.S. holders federal income tax liability. The ability to deduct capital losses may be subject to
limitations.
Estate Taxes. An individual shareholder who is a citizen or resident of the United States for
U.S. federal estate tax purposes will have the value of the equity shares or ADSs held by such
holder included in his or her gross estate for U.S. federal estate tax purposes. An individual
holder who actually pays Indian estate tax with respect to the equity shares will, however, be
entitled to credit the amount of such tax against his or her U.S. federal estate tax liability,
subject to a number of conditions and limitations.
Backup Withholding Tax and Information Reporting Requirements. Any dividends paid, or proceeds
on a sale of, equity shares or ADSs to or by a U.S. holder may be subject to U.S. information
reporting, and a backup withholding tax (currently at a rate of 28% for amounts paid through
December 31, 2010, and 31% thereafter) may apply unless the holder establishes that it is an exempt
recipient or provides a U.S. taxpayer identification number, certifies that such holder is not
subject to backup withholding and otherwise complies with any applicable backup withholding
requirements. Any amount withheld under the backup withholding rules will be allowed as a refund or
credit against the holders U.S. federal income tax, provided that the required information is
furnished to the Internal Revenue Service.
Passive Foreign Investment Company. A non-U.S. corporation will be classified as a passive
foreign investment company for U.S. federal income tax purposes if either:
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75% or more of its gross income for the taxable year, including its pro rata share of the
gross income of any company in which it is considered to own 25% or more of the shares by
value, is passive income; or |
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on average for the taxable year by value, or, if it is not a publicly traded corporation and
so elects, by adjusted basis, if 50% or more of its assets, including its pro rata share of
the assets of any company in which it is considered to own 25% or more of the shares by value,
produce or are held for the production of passive income. |
We do not believe that we satisfied either of the tests for passive foreign investment company
status for our prior taxable year. However, a companys status as a passive foreign investment
company has to be determined on an annual basis. No assurance can be given that we will not be
considered a passive foreign investment company in future taxable years. If we were to be a passive
foreign investment company for any taxable year, U.S. holders would be required to either:
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pay an interest charge together with tax calculated at ordinary income
rates on excess distributions (as the term is defined in relevant
provisions of the Code) and on any gain on a sale or other disposition
of equity shares or ADSs; |
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if a qualified electing fund election (as the term is defined in
relevant provisions of the Code) is made, include in their taxable
income their pro rata share of undistributed amounts of our earnings
and profits, as defined in the Code for these purposes; or |
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if the equity shares or ADSs are marketable (as the term is defined
in relevant provisions of the Code) and a mark-to-market election is
made, mark-to-market the equity shares or ADSs each taxable year and
recognize ordinary gain and, to the extent of prior ordinary gain,
ordinary loss for the increase or decrease in market value for such
taxable year. |
If we are treated as a passive foreign investment company, we do not plan to provide
information necessary for the qualified electing fund election.
The above summary is not intended to constitute a complete analysis of all tax consequences
relating to ownership of equity shares or ADSs. You should consult your own tax advisor concerning
the tax consequences of your particular situation.
10.F. Dividends
Not applicable.
10.G. Statements by experts
Not applicable.
10.H. Documents on display
This report and other information filed or to be filed by us can be inspected and copied at
the public reference facilities maintained by the SEC at Room 1200, 450 Fifth Street, Washington,
DC, U.S.A. These reports and other information may also be accessed via the SECs website at
www.sec.gov.
Additionally, documents referred to in this Form 20-F may be inspected at our corporate
office, which is located at 7-1-27, Ameerpet, Hyderabad, 500016, India.
10.I. Subsidiary information
Not applicable.
ITEM 11. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Market Risk
Market risk is the risk of loss of future earnings or to fair values or to future cash flows
that may result from a change in the price of a financial instrument. The value of a financial
instrument may change as a result of changes in the interest rates, foreign currency exchange rates
and other market changes that affect market risk sensitive instruments. Market risk is attributable
to all market risk sensitive financial instruments including foreign currency receivables and
payables.
Our exposure to market risk is a function of our investment and borrowing activities and our
revenue generating and operating activities in foreign currency. The objective of market risk
management is to avoid excessive exposure in our foreign currency revenues and costs.
We are exposed to market risk primarily related to foreign exchange rate risk, interest rate
risk and the market value of our investments. We actively monitor these exposures. To manage the
volatility relating to these exposures, we enter into a variety of derivative financial instruments
to reduce, where it is deemed appropriate to do so, fluctuations in earnings and cash flows
associated with changes in interest rates and foreign currency rates and to enhance the yield on
the investment. We only sell existing assets in transactions and future transactions (in the case
of anticipatory hedges), which we reasonably expect we will have in the future based on past
experience. Our portfolio is only for hedging purpose.
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Foreign Exchange Rate Risk
We use the Indian rupee as our reporting currency and we are therefore exposed to foreign
exchange movements, primarily in U.S. dollar, Euro, Pound sterling, Russian ruble, Brazilian real
and Asian currencies. Consequently, we enter into various contracts, which change in value as
foreign exchange rates change, to preserve the value of assets, commitments, liabilities and
anticipated transactions. We use forward contracts and foreign currency option contracts to hedge
firm and anticipated net revenues in foreign currencies.
A significant portion of our revenues are in U.S. dollars while a significant portion of our
costs are in Indian rupees. The exchange rate between the Indian rupee and U.S. dollar has
fluctuated significantly in recent years and may continue to fluctuate in the future. Appreciation
of the Indian rupee against the U.S. dollar can adversely affect our results of operations.
We purchase forward foreign exchange contracts and options to mitigate the risk of changes in
foreign exchange rates on accounts receivable and deposits. The forward contracts typically mature
between one and six months. The Indian market for U.S. dollar forward contract is well traded up to
12 months. The counter parties for our exchange contracts are banks and counter party risk is
minimal. Although we believe that these contracts are effective as hedges from an economic
perspective, they do not qualify for hedge accounting under SFAS No. 133, as amended. Any
derivative that is either not designated as a hedge, or is so designated but is ineffective per
SFAS No. 133, is marked to market with resultant differences being recognized in the consolidated
income statement.
The following table sets forth sell U.S. dollars/Indian rupees foreign currency forward
contracts held by us as of March 31, 2005 by maturity month of the contracts:
|
|
|
|
|
|
|
|
|
|
|
|
|
Description |
|
Apr-05 |
|
May-05 |
|
Total |
Contracts Outstanding (U.S.$ million) |
|
|
25 |
|
|
|
5 |
|
|
|
30 |
|
Average Contractual Exchange Rate (U.S.$/Rs.) |
|
|
43.67 |
|
|
|
43.64 |
|
|
|
|
|
The following table sets forth buy U.S. dollars/Indian rupees foreign currency forward
contracts held by us as of March 31, 2005 by maturity month of the contracts:
|
|
|
|
|
|
|
|
|
|
|
|
|
Description |
|
Apr-05 |
|
May-05 |
|
Total |
Contracts Outstanding (U.S.$ million) |
|
|
20 |
|
|
|
20 |
|
|
|
40 |
|
Average Contractual Exchange Rate
(U.S.$/Indian Rupees) |
|
|
44.33 |
|
|
|
43.90 |
|
|
|
|
|
The following table sets forth sell Pound sterling (GBP)/U.S. dollars foreign currency
forward contracts held by us as of March 31, 2005 by maturity month of the contracts:
|
|
|
|
|
Description |
|
May-05 |
Contracts Outstanding (GBP million) |
|
|
2 |
|
Average Contractual Exchange Rate (GBP/U.S.$) |
|
|
1.86 |
|
As of March 31, 2005, the spot exchange rate was Rs.43.7450 per U.S. dollar. For each of
the U.S. dollars/Indian rupees and Pound sterling/ U.S. dollars options, the strike price depends
on the spot exchange rate on the date of expiration of the option.
Increase/(decrease) in fair value of forward contracts and options has been recorded in the
consolidated income statement in the foreign exchange (gain)/loss line item.
Sensitivity analysis of exchange rate risk
A Rs.1 decrease/increase in the spot rate for exchange of Indian rupees with U.S. dollars
would result in approximately Rs.10 million decrease/increase in the fair value of our short U.S.
dollars/Indian rupees currency forward contracts outstanding as of March 31, 2005.
88
A U.S.$0.10 decrease/increase in the spot rate for exchange of U.S. dollars with Pound
Sterling would result in approximately U.S.$0.20 million decrease/increase in the fair value of our
short Pound Sterling/U.S. dollars currency forward contracts outstanding as of March 31, 2005.
Commodity Rate Risk
Our exposure to market risk with respect to commodity prices primarily arises from the fact
that we are a purchaser and seller of active pharmaceutical ingredients and the components for such
active pharmaceutical ingredients. These are commodity products whose prices can fluctuate sharply
over short periods of time. The prices of our raw materials generally fluctuate in line with
commodity cycles, though the prices of raw materials used in our active pharmaceutical ingredients
business are generally more volatile. Raw material expense forms the largest portion of our
operating expenses. We evaluate and manage our commodity price risk exposure through our operating
procedures and sourcing policies.
We do not use any derivative financial instruments or futures contracts to hedge our exposure
to fluctuations in commodity prices.
Interest Rate Risk
As of March 31, 2005 we have no significant long-term borrowings on our books. Our investments
in bank fixed deposits and short-term liquid mutual funds do not expose us to significant interest
rate risk.
Foreign Currency Investments. We have GBP 9.61 million deposits in foreign currency as a
result of our issuance of ADSs. They are placed in fixed deposit GBP instruments. Proceeds from
these deposits are expected to be used to fund overseas expansion of our operations.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long Term Debt |
|
For
the Fiscal Year Ended March 31, |
|
|
2005 |
|
2004 |
|
2003 |
|
|
Amount |
|
Interest Rate |
|
Amount |
|
Interest Rate |
|
Amount |
|
Interest rate |
Fixed rate of
Interest |
|
Rs.31.1 million |
|
|
2 |
*% |
|
Rs.183.7 million |
|
|
2*-4 |
% |
|
Rs.184.7 million |
|
|
2*-4 |
% |
|
|
|
* |
|
Loan received at a subsidized rate of interest from Indian Renewable Energy Development Agency
Limited promoting use of alternative sources of energy. |
Interest Rate Profile. An interest rate profile of long-term debt is given below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Fiscal Year Ended March 31, |
|
|
2005 |
|
2004 |
|
2003 |
Foreign Currency Loans |
|
|
|
|
|
|
4 |
% |
|
|
4 |
% |
Rupee Term Loans |
|
|
2 |
%* |
|
|
2 |
% |
|
|
2-12 |
% |
|
|
|
* |
|
Loan received at a subsidized rate of interest from Indian Renewable Energy Development Agency
Limited promoting use of alternative sources of energy. |
Maturity Profile. A maturity profile of rupee term loans outstanding is as follows:
Maturing in the year ending March 31:
|
|
|
|
|
|
|
Rs. in thousands |
|
2006 |
|
|
5,920 |
|
2007 |
|
|
5,920 |
|
2008 |
|
|
5,920 |
|
2009 |
|
|
5,920 |
|
2010 |
|
|
5,920 |
|
Thereafter |
|
|
1,465 |
|
|
|
|
|
|
|
|
|
31,065 |
|
|
Our major market risks of foreign exchange, interest rate and counter party risk are
managed centrally by our Group Treasury department, which evaluates and exercises independent
control over the entire process of market risk
89
management. The activities of this department include management of cash resources, implementing
hedging strategies for foreign currency exposures, and borrowing strategies.
We have a written Treasury Policy, have implemented a strict segregation of front office, mid
office and back office controls, and we do regular reconciliations of our positions with our
counter parties. In addition, audits of the treasury function are performed at regular intervals.
Counter Party Risk
Counter-party risk encompasses settlement risk on derivative and money market contracts and
credit risk on cash and time deposits. Exposure to these risks is closely monitored and kept within
predetermined parameters. The Group Treasury department does not expect any losses from
non-performance by these counter parties and does not have any significant grouping of exposures to
financial sector or country risk.
Derivative financial instruments
The contract or underlying principal amount of derivative financial instruments (in millions)
at March 31, 2004 and 2005 are set forth by currency in the table below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For
the Fiscal Year Ended March 31, 2005 |
|
For
the Fiscal Year Ended March 31, 2004 |
|
|
U.S. $ |
|
GBP |
|
Rs. |
|
U.S. $ |
|
GBP |
|
Rs. |
|
|
million |
|
million |
|
million |
|
million |
|
million |
|
million |
|
|
|
Currency related instruments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forward foreign exchange rate contracts (sell) |
|
|
30 |
|
|
|
2 |
|
|
|
|
|
|
|
78 |
|
|
|
|
|
|
|
|
|
Forward foreign exchange rate contracts (buy) |
|
|
40 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Over the Counter currency options |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
15 |
|
|
|
6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Currency related derivatives |
|
|
70 |
|
|
|
2 |
|
|
|
|
|
|
|
93 |
|
|
|
6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate related instruments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate swaps |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,500 |
|
Forward rate agreements |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate options |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate related derivatives |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,500 |
|
ITEM 12. DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES
Not applicable.
90
PART II
ITEM 13. DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES
None.
ITEM 14. MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS
Modification in the rights of security holders
None.
Use of Proceeds
On April 11, 2001, we completed our initial U.S. public offering (U.S. IPO), of 13,225,000
American Depositary Shares representing 6,612,500 equity shares of par value Rs.10 per share
(including the exercise of the underwriters over allotment option consisting of 1,725,000 American
Depositary Shares representing 862,500 equity shares) at a public offering price of U.S.$10.04 per
American Depositary Share pursuant to a registration statement filed on Form F-1 (File No.
333-13310) with the SEC.
All of the shares registered were sold before termination of the offering date. The lead
underwriter was Merrill Lynch & Co. and the co-lead underwriters were ABN AMRO Rothschild LLC &
Credit Lyonnais Securities (USA) Inc.
The proceeds of the offering (prior to the underwriting discount and commissions and expenses
of the offering) were U.S.$132.7 million. We paid underwriting discounts and commission of
approximately U.S.$7.3 million. A significant portion of other expenses incurred in connection with
our U.S. IPO was reimbursed by the Depositary. Accordingly, the net proceeds from the offering
after underwriting discounts and commissions was approximately U.S.$125.4 million. None of the net
proceeds from the initial public offering were paid, directly or indirectly, to any of our
directors, officers or general partners or any of their associates, or to any persons owing ten
percent or more of any class of our equity securities, or any affiliates.
In fiscal 2002, we retired U.S.$74.1 million of our liabilities, thereby reducing our interest
outflows substantially. In April 2002, we also invested a sum of U.S.$9.0 million for the
acquisition of U.K. based BMS Laboratories Limited (now Dr. Reddys Laboratories (EU) Limited)
along with its wholly-owned subsidiary Meridian Healthcare Limited (now Dr. Reddys Laboratories
(U.K.) Limited).
The proceeds of the offering were utilized during fiscal 2004 as follows:
|
|
|
|
|
|
|
Amount in |
Particulars |
|
U.S.$ million |
Loan to wholly owned subsidiary and a step down subsidiary |
|
|
5.0 |
|
Payment of contingent consideration in relation to
acquisition of BMS Laboratories Limited |
|
|
0.2 |
|
Total utilization during the year |
|
|
5.2 |
|
The proceeds of the offering were utilized during fiscal 2005 as follows:
|
|
|
|
|
|
|
Amount in |
Particulars |
|
U.S.$ million |
Expenses |
|
|
0.7 |
|
Loan to an affiliate |
|
|
0.9 |
|
Total utilization during the year |
|
|
1.6 |
|
The balance of U.S.$35.5 million has been invested in bank deposits in India as well as
outside India.
91
ITEM 15. CONTROLS AND PROCEDURES
Our officers, after evaluating the effectiveness of our disclosure controls and procedures (as
defined in Exchange Act Rule 13a-15(e)) as of the end of the period covered by this Form 20-F have
concluded that, as of such date, our disclosure controls and procedures were effective. See the
certifications regarding disclosure controls and procedures set forth in Exhibits 99.1, 99.2, 99.3
and 99.4.
During the period covered by this annual report, there were no changes in our internal
controls over financial reporting that have materially affected or are reasonably likely to affect
our internal controls over financial reporting.
ITEM 16. [RESERVED]
ITEM 16.A. AUDIT COMMITTEE FINANCIAL EXPERT
Our Audit Committee is composed of independent directors and brings in expertise in the fields
of finance, economics, human resource development, strategy and management. Please see Item 6.
Directors, Senior Management and Employees for the experience and qualifications of the members of
the Audit Committee. As of March 31, 2005, no member of our audit committee met the requirements to
be an audit committee financial expert under the SEC definition. We believe that the combined
knowledge, skills and experience of the Board of Directors and their authority to engage outside
experts as they deem appropriate to provide them with advice on the matters related to their
responsibilities, enable them, as a group, to act effectively in the fulfillment of their tasks and
responsibilities required under the Sarbanes-Oxley Act of 2002.
ITEM 16.B. CODE OF ETHICS
We have adopted a code of business ethics applicable to our executive officers, directors and
all other employees, including a separate code of ethics applicable to our senior financial
officers. A copy of the code is available, without charge, to all of our employees upon request to
our human resources department, to investors by contacting our investor relations department and to
others if a written request is made to our Company Secretary at our corporate office situated at
7-1-27, Ameerpet, Hyderabad 500 016, Andhra Pradesh, India. The code is also available on our
corporate website, www.drreddys.com. Any waivers of this code for executive officers or directors
will be disclosed through filing of a Form 6-K. In addition, the audit committee of the Board of
Directors has approved a whistleblower policy, which functions in coordination with our code of
business ethics and provides an anonymous means for employees and others to communication with
various internal organizations, including the audit committee of the Board of Directors.
ITEM 16.C. PRINCIPAL ACCOUNTANT FEES AND SERVICES
The following table sets forth for the fiscal years ended March 31, 2004 and March 31, 2005,
the fees paid to our principal accountant and its associated entities for various services they
provided us in these periods.
|
|
|
|
|
|
|
|
|
|
|
Type of Service |
|
Fiscal Year Ended |
|
Description of Services |
|
|
March 31, 2004 |
|
March 31, 2005 |
|
|
|
|
(Rs. in thousands) |
|
|
Audit Fees |
|
|
Rs.8,750 |
|
|
|
Rs.8,575 |
|
|
Audit of financial statements and review of statutory filings |
Audit-Related Fees |
|
|
|
|
|
|
7,049 |
|
|
Services rendered in connection with the review of Sarbanes-Oxley documentation related to future certification |
Tax Fees |
|
|
50 |
|
|
|
225 |
|
|
|
All Other Fees |
|
|
115 |
|
|
|
170 |
|
|
Statutory certifications, other certifications and advisory services |
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
Rs.8,915 |
|
|
|
Rs.16,019 |
|
|
|
|
Our audit committee charter requires us to take the prior approval of our audit committee
on every occasion we engage our principal accountants or their associated entities to provide us
any non-audit services. We disclose to our audit committee the nature of services that are provided
and the fees to be paid for the services. The fees listed in the above table as Tax Fees and
All Other Fees were approved by our audit committee.
92
We changed our U.S. GAAP auditors from KPMG, an Indian partnership (KPMG, India), to KPMG,
LLP, a U.K. limited liability partnership (KPMG, U.K.), for the fiscal year ended March 31, 2004
at the request of KPMG, India. As contemplated and disclosed in the Form 6-K we filed on June 8,
2004, the appointment of KPMG, U.K. as our U.S. GAAP auditors was expected to be transitory with
the re-appointment of KPMG, India as our U.S. GAAP auditors anticipated upon completion of KPMG,
Indias registration with the U.S. Public Company Accounting Oversight Board (the PCAOB).
KPMG, India has notified us of its registration with the PCAOB. The appointment of KPMG,
India as U.S. GAAP auditors for the fiscal year ending March 31, 2005 has been approved by the
Audit Committee of the Company.
We report financial results in accordance with both U.S. GAAP and Indian GAAP. Under the rules
promulgated by the U.S Securities and Exchange Commission (the SEC), the change from KPMG, U.K.
to KPMG, India for fiscal year ending March 31, 2005 constitutes a change in the registrants
certifying accountants.
The reports of KPMG, U.K. on our financial statements for each of the fiscal years ended
March 31, 2003 and 2004 did not contain an adverse opinion or disclaimer of opinion, nor were they
qualified or modified as to uncertainty, audit scope or accounting principles.
During the fiscal years ended March 31, 2003 and 2004 and through the date of change of
auditors, there were no disagreements with KPMG, U.K. on any matter of accounting principle or
practice, financial statement disclosure or auditing scope or procedure which, if not resolved to
the satisfaction of KPMG, U.K., would have caused them to make reference to the subject matter in
connection with their reports on our financial statements for such years. There were no reportable
events as defined in Item 304(a)(1)(v) of Regulation S-K.
ITEM 16.D. EXEMPTION FROM THE LISTING STANDARDS FOR AUDIT COMMITTEE
We have not sought any exemption from the listing standards for audit committees applicable to
us as foreign private issuer.
ITEM 16.E. PURCHASE OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS
During fiscal 2005, there was no purchase made by or on behalf of us or any affiliated
purchaser of shares of any class of our securities that are registered by us pursuant to Section 12
of the Exchange Act.
93
PART III
ITEM 17. FINANCIAL STATEMENTS
Not applicable.
ITEM 18. FINANCIAL STATEMENTS
The following financial statement and auditors report for fiscal 2005 are incorporated herein
by reference and are included in this Item 18 of this report on Form 20-F:
|
|
|
Report of Independent Registered Public Accounting Firm. |
|
|
|
|
Consolidated Balance Sheets as of March 31, 2004 and 2005. |
|
|
|
|
Consolidated Statements of Income for the years ended March 31, 2003, 2004 and 2005. |
|
|
|
|
Consolidated Statements of Stockholders Equity and Comprehensive Income for the years
ended March 31, 2003, 2004 and 2005. |
|
|
|
|
Consolidated Statements of Cash flow for the years ended March 31, 2003, 2004 and 2005. |
|
|
|
|
Notes to the Consolidated Financial Statements. |
94
Report of Independent Registered Public Accounting Firm
The Board of Directors and Stockholders
Dr. Reddys Laboratories Limited
We have audited the accompanying consolidated balance sheets of Dr. Reddys Laboratories Limited
and subsidiaries as of March 31, 2005 and 2004, and the related consolidated statements of
operation, stockholders equity and comprehensive income, and cash flows for each of the years in
the three-year period ended March 31, 2005. These consolidated financial statements are the
responsibility of the Companys management. Our responsibility is to express an opinion on these
consolidated financial statements based on our audits.
We conducted our audits in accordance with the standards of the Public Company Accounting Oversight
Board (United States). Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are free of material misstatement. An
audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the
financial statements. An audit also includes assessing the accounting principles used and
significant estimates made by management, as well as evaluating the overall financial statement
presentation. We believe that our audits provide a reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred to above present fairly, in all
material respects, the financial position of Dr. Reddys Laboratories Limited and subsidiaries as
of March 31, 2005 and 2004, and the results of their operations and their cash flows for each of
the years in the three-year period ended March 31, 2005, in conformity with U.S. generally accepted
accounting principles.
KPMG
Hyderabad, India
May 6, 2005
95
DR. REDDYS LABORATORIES LIMITED AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(in thousands, except share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of March 31, |
|
|
2004 |
|
2005 |
|
2005 |
|
|
|
|
|
|
|
|
|
|
Convenience |
|
|
|
|
|
|
|
|
|
|
translation into |
|
|
|
|
|
|
|
|
|
|
U.S.$ |
|
|
|
|
|
|
|
|
|
|
(unaudited) |
ASSETS |
|
|
|
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
Rs. |
4,376,235 |
|
|
Rs. |
9,287,864 |
|
|
U.S.$ |
212,927 |
|
Investment securities |
|
|
2,536,223 |
|
|
|
310,887 |
|
|
|
7,127 |
|
Restricted cash |
|
|
107,170 |
|
|
|
57,866 |
|
|
|
1,327 |
|
Accounts receivable, net of allowances |
|
|
3,730,139 |
|
|
|
3,587,289 |
|
|
|
82,240 |
|
Inventories |
|
|
3,031,651 |
|
|
|
3,499,606 |
|
|
|
80,229 |
|
Deferred income taxes and deferred charges |
|
|
152,220 |
|
|
|
236,931 |
|
|
|
5,432 |
|
Due from related parties |
|
|
22,437 |
|
|
|
10,812 |
|
|
|
248 |
|
Other current assets |
|
|
1,712,864 |
|
|
|
1,361,578 |
|
|
|
31,215 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
15,668,939 |
|
|
|
18,352,833 |
|
|
|
420,744 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property, plant and equipment, net |
|
|
6,331,135 |
|
|
|
7,058,308 |
|
|
|
161,814 |
|
Due from related parties |
|
|
21,019 |
|
|
|
11,067 |
|
|
|
254 |
|
Investment securities |
|
|
1,563,875 |
|
|
|
995,431 |
|
|
|
22,821 |
|
Investment in affiliates |
|
|
279,182 |
|
|
|
180,894 |
|
|
|
4,147 |
|
Goodwill and intangible assets |
|
|
2,665,620 |
|
|
|
2,588,381 |
|
|
|
59,339 |
|
Other assets |
|
|
89,533 |
|
|
|
101,446 |
|
|
|
2,326 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets |
|
Rs. |
26,619,303 |
|
|
Rs. |
29,288,360 |
|
|
U.S.$ |
671,443 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
Borrowings from banks |
|
|
320,582 |
|
|
|
2,796,330 |
|
|
|
64,107 |
|
Current portion of long-term debt |
|
|
152,658 |
|
|
|
5,920 |
|
|
|
136 |
|
Trade accounts payable |
|
|
2,174,295 |
|
|
|
1,415,648 |
|
|
|
32,454 |
|
Due to related parties |
|
|
201,170 |
|
|
|
139,503 |
|
|
|
3,198 |
|
Accrued expenses |
|
|
1,244,082 |
|
|
|
2,375,087 |
|
|
|
54,450 |
|
Other current liabilities |
|
|
472,888 |
|
|
|
849,434 |
|
|
|
19,473 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
4,565,675 |
|
|
|
7,581,922 |
|
|
|
173,818 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term debt, excluding current portion |
|
|
31,065 |
|
|
|
25,145 |
|
|
|
576 |
|
Deferred revenue |
|
|
288,382 |
|
|
|
58,255 |
|
|
|
1,336 |
|
Deferred income taxes |
|
|
571,558 |
|
|
|
551,789 |
|
|
|
12,650 |
|
Other liabilities |
|
|
123,265 |
|
|
|
118,090 |
|
|
|
2,707 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
Rs. |
5,579,945 |
|
|
Rs. |
8,335,201 |
|
|
U.S.$ |
191,087 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders equity: |
|
|
|
|
|
|
|
|
|
|
|
|
Equity shares at Rs.5 par value; 100,000,000 shares
authorized; Issued and outstanding; 76,518,949 shares
and 76,518,949 shares as of March 31, 2004 and 2005
respectively |
|
Rs. |
382,595 |
|
|
|
382,595 |
|
|
|
8,771 |
|
Additional paid-in capital |
|
|
10,089,152 |
|
|
|
10,089,152 |
|
|
|
231,296 |
|
Equity-options outstanding |
|
|
256,748 |
|
|
|
400,749 |
|
|
|
9,187 |
|
Retained earnings |
|
|
10,229,672 |
|
|
|
10,009,305 |
|
|
|
229,466 |
|
Equity shares held by a controlled trust: 41,400 shares |
|
|
(4,882 |
) |
|
|
(4,882 |
) |
|
|
(112 |
) |
Accumulated other comprehensive income |
|
|
86,073 |
|
|
|
76,240 |
|
|
|
1,748 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders equity |
|
|
21,039,358 |
|
|
|
20,953,159 |
|
|
|
480,357 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity |
|
Rs. |
26,619,303 |
|
|
Rs. |
29,288,360 |
|
|
U.S.$ |
671,443 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to the consolidated financial statements.
F-1
DR. REDDYS LABORATORIES LIMITED AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATION
(in thousands, except share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Year ended March 31, |
|
|
2003 |
|
2004 |
|
2005 |
|
2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convenience |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
translation into |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(unaudited) |
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales, net of allowances for sales
returns (includes excise duties of Rs.817,135,
and Rs.870,079 Rs.815,007 for the years ended
March 31, 2003, 2004 and 2005 respectively) |
|
Rs. |
18,069,812 |
|
|
Rs. |
20,081,249 |
|
|
Rs. |
19,126,188 |
|
|
U.S.$ |
438,473 |
|
License fees |
|
|
|
|
|
|
|
|
|
|
345,737 |
|
|
|
7,926 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
18,069,812 |
|
|
|
20,081,249 |
|
|
|
19,471,925 |
|
|
|
446,399 |
|
Cost of revenues |
|
|
7,847,573 |
|
|
|
9,346,117 |
|
|
|
9,385,820 |
|
|
|
215,172 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
10,222,239 |
|
|
|
10,735,132 |
|
|
|
10,086,105 |
|
|
|
231,227 |
|
Operating expenses, net: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative expenses |
|
|
5,103,213 |
|
|
|
6,562,856 |
|
|
|
6,810,434 |
|
|
|
156,131 |
|
Research and development expenses, net |
|
|
1,411,838 |
|
|
|
1,991,629 |
|
|
|
2,803,311 |
|
|
|
64,267 |
|
Amortization expenses |
|
|
419,439 |
|
|
|
382,857 |
|
|
|
349,991 |
|
|
|
8,024 |
|
Foreign exchange (gain)/loss |
|
|
70,108 |
|
|
|
(282,419 |
) |
|
|
488,819 |
|
|
|
11,206 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses, net |
|
|
7,004,598 |
|
|
|
8,654,923 |
|
|
|
10,452,555 |
|
|
|
239,627 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income/(loss) |
|
|
3,217,641 |
|
|
|
2,080,209 |
|
|
|
(366,450 |
) |
|
|
(8,400 |
) |
Equity in loss of affiliates |
|
|
(92,094 |
) |
|
|
(44,362 |
) |
|
|
(58,101 |
) |
|
|
(1,332 |
) |
Other (expense)/income, net |
|
|
683,124 |
|
|
|
504,191 |
|
|
|
531,580 |
|
|
|
12,186 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before income taxes and minority interest |
|
|
3,808,671 |
|
|
|
2,540,038 |
|
|
|
107,029 |
|
|
|
2,454 |
|
Income taxes (expense)/benefit |
|
|
(398,062 |
) |
|
|
(69,249 |
) |
|
|
94,277 |
|
|
|
2,161 |
|
Minority interest |
|
|
(6,734 |
) |
|
|
3,364 |
|
|
|
9,942 |
|
|
|
228 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
Rs. |
3,403,875 |
|
|
Rs. |
2,474,153 |
|
|
Rs. |
211,248 |
|
|
U.S.$ |
4,843 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per equity share |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
44.49 |
|
|
|
32.34 |
|
|
|
2.76 |
|
|
|
0.06 |
|
Diluted |
|
|
44.49 |
|
|
|
32.32 |
|
|
|
2.76 |
|
|
|
0.06 |
|
Weighted average number of equity shares used in
computing earnings per equity share |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
76,515,948 |
|
|
|
76,513,764 |
|
|
|
76,518,949 |
|
|
|
76,518,949 |
|
Diluted |
|
|
76,515,948 |
|
|
|
76,549,598 |
|
|
|
76,559,801 |
|
|
|
76,559,801 |
|
See accompanying notes to the consolidated financial statements.
F-2
DR. REDDYS LABORATORIES LIMITED AND SUBSIDIARIES
CONSOLIDATED STATEMENT OF STOCKHOLDERS EQUITY AND COMPREHENSIVE INCOME
(in thousands, except share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity Shares held by a |
|
|
Equity Shares |
|
|
|
|
|
|
|
|
|
Controlled Trust |
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
|
|
|
|
|
|
No. of |
|
|
|
|
|
Paid In |
|
Comprehensive |
|
No. of |
|
|
|
|
shares |
|
Amount |
|
Capital |
|
Income |
|
shares |
|
Amount |
Balance as of March 31, 2002 |
|
|
76,515,948 |
|
|
Rs. |
382,580 |
|
|
Rs. |
10,085,004 |
|
|
|
|
|
|
|
41,400 |
|
|
|
(4,882 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dividends |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss for the quarter ended March 31, 2003
for the change in the fiscal year end of a
consolidated subsidiary |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
|
|
|
|
|
|
|
|
|
|
|
|
Rs. |
3,403,875 |
|
|
|
|
|
|
|
|
|
Translation adjustment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
38,073 |
|
|
|
|
|
|
|
38,073 |
|
Unrealized gain on investments,
net of tax |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
28 |
|
|
|
|
|
|
|
28 |
|
Comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
Rs. |
3,441,976 |
|
|
|
|
|
|
|
|
|
Application of SFAS 123 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of March 31, 2003 |
|
|
76,515,948 |
|
|
Rs. |
382,580 |
|
|
Rs. |
10,085,004 |
|
|
|
|
|
|
|
41,400 |
|
|
Rs. |
(4,882 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of equity shares on exercise of options |
|
|
3,001 |
|
|
|
15 |
|
|
|
4,148 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Dividends |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
|
|
|
|
|
|
|
|
|
|
|
|
Rs. |
2,474,153 |
|
|
|
|
|
|
|
|
|
Translation adjustment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
24,725 |
|
|
|
|
|
|
|
|
|
Unrealized gain on investments, net of tax |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
15,020 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
Rs. |
2,513,898 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Application of SFAS 123 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of March 31, 2004 |
|
|
76,518,949 |
|
|
Rs. |
382,595 |
|
|
Rs. |
10,089,152 |
|
|
|
|
|
|
|
41,400 |
|
|
Rs. |
(4,882 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dividend paid |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
|
|
|
|
|
|
|
|
|
|
|
|
Rs. |
211,248 |
|
|
|
|
|
|
|
|
|
Translation adjustment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13,512 |
|
|
|
|
|
|
|
|
|
Unrealized loss on investments,
net of tax |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(23,345 |
) |
|
|
|
|
|
|
|
|
Comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
Rs. |
201,415 |
|
|
|
|
|
|
|
|
|
Application of SFAS 123 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of March 31, 2005 |
|
|
76,518,949 |
|
|
Rs. |
382,595 |
|
|
Rs. |
10,089,152 |
|
|
|
|
|
|
|
41,400 |
|
|
Rs. |
(4,882 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convenience translation into U.S.$ |
|
|
|
|
|
US$ |
8,771 |
|
|
US$ |
231,296 |
|
|
|
|
|
|
|
|
|
|
US$ |
(112 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(unaudited)
[Additional Columns Below]
See accompanying notes to the consolidated financial statements.
F-3
[Continued from above table, first column(s) repeated]
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
Retained |
|
|
|
|
Other |
|
Equity - |
|
Earnings/ |
|
Total |
|
|
Comprehensive |
|
Options |
|
(Accumulated |
|
Stockholders |
|
|
Income |
|
Outstanding |
|
Deficit) |
|
Equity |
Balance as of March 31, 2002 |
|
|
8,227 |
|
|
|
7,211 |
|
|
|
4,979,292 |
|
|
|
15,457,432 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dividends |
|
|
|
|
|
|
|
|
|
|
(191,290 |
) |
|
|
(191,290 |
) |
Net loss for the quarter ended March 31, 2003
for the change in the fiscal year end of a
consolidated subsidiary |
|
|
|
|
|
|
|
|
|
|
(4,760 |
) |
|
|
(4,760 |
) |
Comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
|
|
|
|
|
|
|
|
|
3,403,875 |
|
|
|
3,403,875 |
|
Translation adjustment |
|
|
38,073 |
|
|
|
|
|
|
|
|
|
|
|
38,073 |
|
Unrealized gain on investments,
net of tax |
|
|
28 |
|
|
|
|
|
|
|
|
|
|
|
28 |
|
Comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Application of SFAS 123 |
|
|
|
|
|
|
128,483 |
|
|
|
|
|
|
|
128,483 |
|
Balance as of March 31, 2003 |
|
Rs. |
46,328 |
|
|
Rs. |
135,694 |
|
|
Rs. |
8,187,117 |
|
|
Rs. |
18,831,841 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of equity shares on exercise of options |
|
|
|
|
|
|
(1,123 |
) |
|
|
|
|
|
|
3,040 |
|
Dividends |
|
|
|
|
|
|
|
|
|
|
(431,598 |
) |
|
|
(431,598 |
) |
Comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
|
|
|
|
|
|
|
|
|
2,474,153 |
|
|
|
2,474,153 |
|
Translation adjustment |
|
|
24,725 |
|
|
|
|
|
|
|
|
|
|
|
24,725 |
|
Unrealized gain on investments, net of tax |
|
|
15,020 |
|
|
|
|
|
|
|
|
|
|
|
15,020 |
|
Comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Application of SFAS 123 |
|
|
|
|
|
|
122,177 |
|
|
|
|
|
|
|
122,177 |
|
Balance as of March 31, 2004 |
|
Rs. |
86,073 |
|
|
Rs. |
256,748 |
|
|
Rs. |
10,229,672 |
|
|
Rs. |
21,039,358 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dividend paid |
|
|
|
|
|
|
|
|
|
|
(431,615 |
) |
|
|
(431,615 |
) |
Comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
|
|
|
|
|
|
|
|
|
211,248 |
|
|
|
211,248 |
|
Translation adjustment |
|
|
13,512 |
|
|
|
|
|
|
|
|
|
|
|
13,512 |
|
Unrealized loss on investments,
net of tax |
|
|
(23,345 |
) |
|
|
|
|
|
|
|
|
|
|
(23,345 |
) |
Comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Application of SFAS 123 |
|
|
|
|
|
|
144,001 |
|
|
|
|
|
|
|
144,001 |
|
Balance as of March 31, 2005 |
|
Rs. |
76,240 |
|
|
Rs. |
400,749 |
|
|
Rs. |
10,009,305 |
|
|
Rs. |
20,953,159 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convenience translation into U.S.$(unaudited) |
|
US$ |
1,748 |
|
|
US$ |
9,187 |
|
|
US$ |
229,466 |
|
|
US$ |
480,357 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to the consolidated financial statements.
F-4
DR. REDDYS LABORATORIES LIMITED AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands, except share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended March 31, |
|
|
2003 |
|
2004 |
|
2005 |
|
2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convenience |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
translation into |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(unaudited) |
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
Rs. |
3,403,875 |
|
|
Rs. |
2,474,153 |
|
|
Rs. |
211,248 |
|
|
U.S.$ |
4,843 |
|
Adjustments to reconcile net income to net cash from operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred tax expense / (benefit) |
|
|
547 |
|
|
|
(134,867 |
) |
|
|
(95,580 |
) |
|
|
(2,191 |
) |
Gain on sale of available for sale securities, net |
|
|
(6,284 |
) |
|
|
(24,786 |
) |
|
|
(64,997 |
) |
|
|
(1,490 |
) |
Depreciation and amortization |
|
|
1,017,813 |
|
|
|
1,128,453 |
|
|
|
1,309,290 |
|
|
|
30,016 |
|
In-process research and development expensed |
|
|
|
|
|
|
|
|
|
|
277,343 |
|
|
|
6,358 |
|
Loss/(profit) on sale of property, plant and equipment |
|
|
248 |
|
|
|
29,319 |
|
|
|
(1,810 |
) |
|
|
(41 |
) |
Provision for doubtful accounts receivable |
|
|
93,883 |
|
|
|
19,871 |
|
|
|
79,442 |
|
|
|
1,821 |
|
Allowance for sales returns |
|
|
193,229 |
|
|
|
169,511 |
|
|
|
105,245 |
|
|
|
2,413 |
|
Inventory write-downs |
|
|
34,239 |
|
|
|
31,898 |
|
|
|
52,692 |
|
|
|
1,208 |
|
Write-down of investment |
|
|
1,679 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity in loss of affiliates |
|
|
92,094 |
|
|
|
44,362 |
|
|
|
58,101 |
|
|
|
1,332 |
|
Unrealized exchange (gain)/loss |
|
|
79,947 |
|
|
|
(109,602 |
) |
|
|
105,227 |
|
|
|
2,412 |
|
Employees stock based compensation |
|
|
128,483 |
|
|
|
122,177 |
|
|
|
144,001 |
|
|
|
3,301 |
|
Loss on sale of subsidiary interest |
|
|
|
|
|
|
58,473 |
|
|
|
8,122 |
|
|
|
186 |
|
Minority interest |
|
|
6,734 |
|
|
|
(3,364 |
) |
|
|
(9,942 |
) |
|
|
(228 |
) |
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
159,697 |
|
|
|
(379,413 |
) |
|
|
77,368 |
|
|
|
1,774 |
|
Inventories |
|
|
(440,856 |
) |
|
|
(335,092 |
) |
|
|
(514,187 |
) |
|
|
(11,788 |
) |
Other assets |
|
|
(665,278 |
) |
|
|
(276,467 |
) |
|
|
142,486 |
|
|
|
3,267 |
|
Due to / from related parties, net |
|
|
5,997 |
|
|
|
148,576 |
|
|
|
(40,249 |
) |
|
|
(923 |
) |
Trade accounts payable |
|
|
584,958 |
|
|
|
690,182 |
|
|
|
(763,523 |
) |
|
|
(17,504 |
) |
Accrued expenses |
|
|
66,357 |
|
|
|
510,768 |
|
|
|
1,094,768 |
|
|
|
25,098 |
|
Deferred revenue |
|
|
|
|
|
|
|
|
|
|
(247,604 |
) |
|
|
(5,676 |
) |
Taxes payable |
|
|
(113,903 |
) |
|
|
(115,375 |
) |
|
|
42,513 |
|
|
|
975 |
|
Other liabilities |
|
|
(276,727 |
) |
|
|
(49,547 |
) |
|
|
321,657 |
|
|
|
7,374 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by operating activities |
|
|
4,366,732 |
|
|
|
3,999,230 |
|
|
|
2,291,611 |
|
|
|
52,536 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted cash |
|
|
(1,524 |
) |
|
|
(67,221 |
) |
|
|
49,304 |
|
|
|
1,130 |
|
Expenditure on property, plant and equipment |
|
|
(1,515,721 |
) |
|
|
(2,415,638 |
) |
|
|
(1,749,172 |
) |
|
|
(40,100 |
) |
Proceeds from sale of property, plant and equipment |
|
|
4,311 |
|
|
|
33,558 |
|
|
|
44,673 |
|
|
|
1,024 |
|
Investment in affiliate |
|
|
|
|
|
|
(63,238 |
) |
|
|
(49,935 |
) |
|
|
(1,145 |
) |
Purchase of investment securities |
|
|
(2,933,474 |
) |
|
|
(13,178,735 |
) |
|
|
(10,226,471 |
) |
|
|
(234,445 |
) |
Proceeds from sale of investment securities |
|
|
2,939,603 |
|
|
|
9,167,150 |
|
|
|
13,079,463 |
|
|
|
299,850 |
|
Expenditure on intangible assets |
|
|
(30,404 |
) |
|
|
(105 |
) |
|
|
(8,299 |
) |
|
|
(190 |
) |
Acquisition of minority interest |
|
|
(3,208 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from sale of subsidiary, net |
|
|
|
|
|
|
81,464 |
|
|
|
29,000 |
|
|
|
665 |
|
Cash paid for acquisition, net of cash acquired |
|
|
(414,279 |
) |
|
|
(63,290 |
) |
|
|
(535,665 |
) |
|
|
(12,280 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by / (used in) in investing activities |
|
|
(1,954,696 |
) |
|
|
(6,506,055 |
) |
|
|
632,898 |
|
|
|
14,509 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance of equity, net of expenses |
|
|
|
|
|
|
3,040 |
|
|
|
|
|
|
|
|
|
Proceeds from issuance of equity, in subsidiary |
|
|
|
|
|
|
2,435 |
|
|
|
|
|
|
|
|
|
Purchase of treasury stock |
|
|
|
|
|
|
(115,990 |
) |
|
|
|
|
|
|
|
|
Proceeds from borrowing from banks, net |
|
|
43,700 |
|
|
|
177,071 |
|
|
|
2,520,409 |
|
|
|
57,781 |
|
Proceeds from issuance from long-term debt |
|
|
1,009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Repayment of long-term debt |
|
|
(6,440 |
) |
|
|
(11,072 |
) |
|
|
(157,476 |
) |
|
|
(3,610 |
) |
Dividends |
|
|
(191,290 |
) |
|
|
(431,598 |
) |
|
|
(431,615 |
) |
|
|
(9,895 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by/(used in) financing activities |
|
|
(153,021 |
) |
|
|
(376,114 |
) |
|
|
1,931,318 |
|
|
|
44,276 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange rate changes on cash and cash equivalents |
|
|
(94,991 |
) |
|
|
(14,224 |
) |
|
|
55,802 |
|
|
|
1,279 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase / (decrease) in cash and cash equivalents during the year |
|
|
2,164,024 |
|
|
|
(2,897,163 |
) |
|
|
4,911,629 |
|
|
|
112,600 |
|
Cash and cash equivalents at the beginning of the year |
|
|
5,109,374 |
|
|
|
7,273,398 |
|
|
|
4,376,235 |
|
|
|
100,326 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at the end of the year |
|
Rs. |
7,273,398 |
|
|
Rs. |
4,376,235 |
|
|
Rs. |
9,287,864 |
|
|
U.S.$ |
212,927 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-5
DR. REDDYS LABORATORIES LIMITED AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands, except share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended March 31, |
|
|
2003 |
|
2004 |
|
2005 |
|
2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convenience |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
translation into |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
US$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(unaudited) |
Supplemental disclosures: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid for: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest (net of interest capitalized) |
|
Rs. |
34,465 |
|
|
Rs. |
11,234 |
|
|
Rs. |
98,337 |
|
|
U.S.$ |
2,254 |
|
Income taxes |
|
|
682,285 |
|
|
|
425,144 |
|
|
|
|
|
|
|
|
|
Supplemental schedule of non-cash investing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property, plant and equipment purchased on credit during the year |
|
|
167,920 |
|
|
|
36,710 |
|
|
|
22,827 |
|
|
|
523 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Treasury stock issued on acquisition of minority interest including compensation cost |
|
|
|
|
|
|
115,990 |
|
|
|
|
|
|
|
|
|
See accompanying notes to the consolidated financial statements
F-6
DR. REDDYS LABORATORIES LIMITED AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(in thousands, except share data and where otherwise stated)
1. Overview
Dr. Reddys Laboratories Limited (DRL) together with its subsidiaries (collectively, the
Company) is a leading India-based pharmaceutical company headquartered in Hyderabad, India. The
Companys principal areas of operation are formulations, active pharmaceutical ingredients and
intermediates, generics, critical care and biotechnology, and drug discovery. The Companys
principal research and development and manufacturing facilities are located in Andhra Pradesh,
India with principal marketing facilities in India, Russia, the United States, the United Kingdom
and Brazil. The Companys shares trade on several stock exchanges in India and, since April 11,
2001, on the New York Stock Exchange in the United States. The list of subsidiaries is as follows:
|
§ |
|
DRL Investments Limited |
|
|
§ |
|
Reddy Pharmaceuticals Hong Kong Limited (RPHL) |
|
|
§ |
|
Reddy Antilles N.V. (RANV) |
|
|
§ |
|
Reddy US Therapeutics Inc. (Reddy US) |
|
|
§ |
|
Dr. Reddys Laboratories Inc. (DRLI) |
|
|
§ |
|
Dr. Reddys Farmaceutica Do Brazil Ltda. (DRFBL) |
|
|
§ |
|
Aurigene Discovery Technologies Limited (ADTL) |
|
|
§ |
|
Dr. Reddys Laboratories (EU) Limited (DRL EU) |
|
|
§ |
|
Dr. Reddys Laboratories (Proprietary) Limited
(DRSA) |
|
|
§ |
|
AMPNH Inc., USA |
|
|
§ |
|
Reddy Pharmaceuticals, Inc. USA (RPI) |
|
|
§ |
|
OOO Dr. Reddys Laboratories Limited, Russia |
|
|
§ |
|
OOO JV Reddy Biomed Limited (Reddy Biomed or RBL) |
|
|
§ |
|
Reddy Netherlands B.V. (RNBV) |
|
|
§ |
|
Reddy Cheminor SA (RCSA) |
|
|
§ |
|
Aurigene Discovery Technologies Inc. (ADTI) |
|
|
§ |
|
Dr. Reddys Laboratories (U.K.) Limited (DRL U.K.) |
|
|
§ |
|
Cheminor Investment Limited |
|
|
§ |
|
Dr, Reddys Bio-sciences Limited |
|
|
§ |
|
Trigenesis Therapeutics Inc. (Trigenesis) |
2. Significant accounting policies
a) Basis of preparation
The accompanying consolidated financial statements have been prepared in accordance with the
accounting principles generally accepted in the United States (U.S. GAAP). The preparation of
consolidated financial statements in conformity with U.S. GAAP requires management to make
estimates and assumptions that affect the reported amounts of assets and liabilities, revenues and
expenses and disclosure of contingent assets and liabilities. Actual results could differ from
these estimates.
b) Functional currency
The functional currency of the Company is the Indian rupee, including its consolidated foreign
subsidiaries, except Reddy US, DRL EU, DRL U.K. and ADTI, being the currency of the primary
economic environment in which the Company operates. The functional currency of Reddy US and ADTI,
is the U.S. dollar and of DRL EU and DRL U.K., is the Pound sterling, being the currency of the
primary economic environment in which they operate.
All other foreign subsidiaries, (i.e., those except Reddy US, DRL EU, DRL U.K. and ADTI)
operate as marketing arms of the parent company in their respective countries/regions.
Accordingly, the operations of these entities are largely restricted to import of
finished goods from the parent company in India, sale of these products in the foreign country
and remittance of the sale proceeds to the parent. The cash flows realized from sale of goods are
readily available for remittance to the parent company and cash is remitted to the parent company
on a regular basis. The costs incurred by these entities are primarily the cost of goods imported
from the parent. The financing of these subsidiaries is done directly or indirectly by the parent
company. Based on an individual and
F-7
DR. REDDYS LABORATORIES LIMITED AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(in thousands, except share data and where otherwise stated)
2. Significant accounting policies (continued)
collective evaluation of these economic factors, management has determined that the Indian
rupee is the functional currency of these entities.
In respect of the subsidiaries for which the foreign currency is their respective functional
currency, the assets and liabilities of such subsidiaries are translated into Indian rupees at the
rate of exchange prevailing as at the balance sheet date. Revenues and expenses are translated into
Indian rupees at average monthly exchange rates prevailing during the year. Resulting translation
adjustments are included in accumulated other comprehensive income.
c) Convenience translation
The accompanying financial statements have been prepared in Indian rupees, the national
currency of India. Solely for the convenience of the reader, the financial statements as of and
for the year ended March 31, 2005 have been translated into United States dollars at the noon
buying rate in New York City on March 31, 2005 for cable transfers in Indian rupees, as certified
for customs purposes by the Federal Reserve Bank of New York of U.S.$1 = Rs.43.62 No representation
is made that the Indian rupee amounts have been, could have been or could be converted into United
States dollars at such a rate or any other rate.
d) Principles of consolidation
The consolidated financial statements include the financial statements of DRL, all of its
subsidiaries, which are more than 50% owned and controlled, entities where the Company has variable
interest and Dr. Reddys Research Foundation (the Research Foundation), a special purpose entity
that is funded by and carries out research activities on behalf of and for the benefit of the
Company. The Company does not consolidate entities where the minority shareholders have certain
significant participating rights which provide for effective involvement in significant decisions
in the ordinary course of business. Such investments are accounted by the equity method of
accounting. All material inter-company balances and transactions are eliminated on consolidation.
The Company accounts for investments by the equity method of accounting where it is able to
exercise significant influence over the operating and financing policies of the investee. The
Companys equity in the income / loss of equity method affiliates, Aurantis Farmaceutica Ltda,
Brazil (Aurantis), Reddy Kunshan, Compact Electric Limited and Pathnet India Private Limited
(Pathnet), is included in the statement of operations. Inter company profits and losses have been
eliminated until realized by the investor or investee.
Newly acquired subsidiaries have been included in the consolidated financial statements from
dates of acquisition. Effective January 2004, the Company adopted FASB Interpretation No. 46
(revised December 2003), Consolidation of Variable Interest Entities (VIE), which addresses how a
business enterprise should evaluate whether it has a controlling financial interest in an entity
through means other than voting rights and accordingly should consolidate the entity.
For any VIEs that must be consolidated under Financial Accounting Standards Board
Interpretation (FIN) 46R that were created after January 1, 2004, the interpretation generally
requires the primary beneficiary initially to measure the assets, liabilities and noncontrolling
interests of the newly consolidated VIE at their fair values at the date the enterprise first
becomes the primary beneficiary.
Based on the evaluation on FIN 46R, the Company has consolidated the financial statements of
APR LLC, a VIE. See footnote 14 for additional information required by FIN 46R.
F-8
DR. REDDYS LABORATORIES LIMITED AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(in thousands, except share data and where otherwise stated)
2. Significant accounting policies (continued)
e) Cash equivalents
The Company considers all highly liquid investments with remaining maturities, at the date of
purchase / investment, of three months or less to be cash equivalents.
f) Revenue recognition
Product sales
Revenue is recognized when significant risks and rewards in respect of ownership of products
are transferred to customers, generally, the stockists or formulations manufacturers and when the
following criteria are met:
|
|
|
Persuasive evidence of an arrangement exists; |
|
|
|
|
The price to the buyer is fixed and determinable; and |
|
|
|
|
Collectibility of the sales price is reasonably assured. |
Revenue from domestic sales of formulation products is recognized on dispatch of the product
to the stockist by the consignment and clearing and forwarding agent of the Company. Revenue from
domestic sales of active pharmaceutical ingredients and intermediates is recognized on dispatch of
products to customers, from the factories of the Company. Revenue from export sales is recognized
when significant risks and rewards are transferred to customers, which is based on terms of
contract.
Revenue from product sales includes excise duty and is shown net of sales tax and applicable
discounts and allowances.
Sales of formulations in India are made through clearing and forwarding agents to stockists.
Significant risks and rewards in respect of ownership of formulation products is transferred by the
Company when the goods are shipped to stockists from clearing and forwarding agents. Clearing and
forwarding agents are generally compensated on a commission basis as a percentage of sales made by
them.
Sales of active pharmaceutical ingredients and intermediates in India are made directly to the
end customers generally, formulation manufacturers, from the factories. Sales of formulations and
active pharmaceutical ingredients and intermediates outside India are made directly to the end
customers, generally stockists or formulations manufacturers, from the Company or its consolidated
subsidiaries.
The Company has entered into marketing arrangements with certain marketing partners for sale
of goods. Under such arrangements, the Company sells generic products to the marketing partners at
a price agreed in the arrangement. Revenue is recognized on these transactions upon delivery of
products to the marketing partners as all the conditions under Staff Accounting Bulletin No.104
(SAB 104) are met. Subsequently, the marketing partners remit an additional amount upon further
sales made by them to the end customer. Such amount is determined as per the terms of the
arrangement and is recognized by the Company when the realization is certain under the guidance
given in SAB 104.
The Company has entered into certain dossier sales, licensing and supply arrangements that
include certain performance obligations. Based on an evaluation of whether or not these
obligations are inconsequential or perfunctory, the Company defers the upfront payments received
towards these arrangements. Such deferred amounts are recognized in the income statement in the
period in which the Company completes its remaining performance obligations.
Allowances for sales returns are estimated and provided for in the year of sales. Such
allowances are made based on the historical trends. The Company has the ability to make a
reasonable estimate of the amount of future returns due to large volumes of homogeneous
transactions and historical experience with similar types of sales of products. In respect of new
products for which sales have commenced or are expected to commence, the sales returns are not
expected to be different from the existing products as such products relate to the therapeutic
categories where established products exist and are sold in the market. Further, the Company
evaluates the sales returns of all the products at the end of each reporting period and necessary
adjustments, if any, are made. However, no significant revisions have been determined to be
necessary to date.
F-9
DR. REDDYS LABORATORIES LIMITED AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(in thousands, except share data and where otherwise stated)
2. Significant accounting policies (continued)
License fees
Non-refundable milestone payments are recognized in the statement of income when earned, in
accordance with the terms prescribed in the license agreement, and where the Company has no future
obligations or continuing involvement pursuant to such milestone payments. Non-refundable up-front
license fees are deferred and recognized when the milestones are earned, in proportion that the
amount of each milestone earned bears to the total milestone amounts agreed in the license
agreement. As the upfront license fees are a composite amount and cannot be attributed to a
specific molecule, they are amortized over the development period. The milestone payments during
the development period increase as the risk involved decreases. The agreed milestone payments
reflect the progress of the development of the molecule and may not be spread evenly over the
development period. Further, the milestone payments are a fair representation of the extent of
progress made in the development of these molecules. Hence, the upfront license fees are amortized
over the development period in proportion to the milestone payments received. In the event, the
development is discontinued, the corresponding amount of deferred revenue is recognized in the
income statement in the period in which the project is effectively terminated.
g) Shipping and handling costs
Shipping and handling costs incurred to transport products to customers are included in
selling, general and administrative expenses.
h) Inventories
Inventories are stated at the lower of cost or market value. Cost is determined using the
first-in-first-out method for all categories of inventories except stores and spares, where cost is
determined using the weighted average method. Stores and spares comprise engineering spares such
as machinery spares and consumables such as lubricants, cotton waste and oils, which are used in
operating machines or consumed as indirect materials in the manufacturing process. Cost in the
case of raw materials and stores and spares comprises the purchase price and attributable direct
costs, less trade discounts. Cost in the case of work-in-process and finished goods comprises
direct labor, material costs and production overheads.
A write-down of inventory to the lower of cost or market value at the close of a fiscal period
creates a new cost basis and is not marked up based on changes in underlying facts and
circumstances.
Inventories are reviewed on a monthly basis for identification and write-off of slow-moving,
obsolete and impaired inventory. Such write-downs, if any, are included in cost of goods sold.
i) Investment securities
Investment securities consist of available for sale debt and equity securities and
non-marketable equity securities accounted for by the cost method.
Available for sale securities are carried at fair value based on quoted market prices. For
debt securities where quoted market prices are not available, fair value is determined using
pricing techniques such as discounted cash flow analysis or at the swap rates and forward rate
agreements on the date of the valuation, obtained from market sources. Unrealized holding gains and
losses, net of the related tax effect, on available for sale securities are excluded from earnings
and are reported as a separate component of stockholders equity until realized. Decline in the
fair value of any available for sale security below cost that is determined to be other than
temporary, results in reduction in the carrying amount to fair value. Such impairment is charged to
the statement of operations. Realized gains and losses from the sale of available for sale
securities are determined on a first-in-first-out method and are included in earnings.
Non-marketable equity securities accounted for by the cost method are stated at cost, less
provision for any other than temporary decline in value.
F-10
DR. REDDYS LABORATORIES LIMITED AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(in thousands, except share data and where otherwise stated)
2. Significant accounting policies (continued)
j) Derivative financial instruments
The Company enters into forward foreign exchange contracts and options where the counterparty
is generally a bank. The Company purchases forward foreign exchange contracts and options to
mitigate the risk of changes in foreign exchange rates on accounts receivable and deposits.
Although the Company believes that these contracts are effective as hedges from an economic
perspective, they do not qualify for hedge accounting under SFAS No. 133, as amended. Any
derivative that is either not designated as a hedge, or is so designated but is ineffective per
SFAS No. 133, is marked to market and recognized in income immediately.
k) Property, plant and equipment
Property, plant and equipment including assets acquired under capital lease agreements are
stated at cost less accumulated depreciation. The Company depreciates property, plant and
equipment over the estimated useful life using the straight-line method. Assets under capital
leases are amortized over their estimated useful life or the lease term as appropriate. The
estimated useful lives of assets are as follows:
|
|
|
Buildings |
|
|
-Factory and administrative buildings |
|
30 to 40 years |
-Ancillary structures |
|
3 to 10 years |
Plant and machinery |
|
3 to 15 years |
Furniture, fixtures and office equipment |
|
4 to 8 years |
Vehicles |
|
4 to 5 years |
Computer equipment |
|
3 years |
Advances paid towards the acquisition of property, plant and equipment outstanding at each
balance sheet date and the cost of property, plant and equipment not put to use before such date
are disclosed under capital work-in-progress. The interest cost incurred for funding an asset
during its construction period is capitalized based on the actual investment in the asset and the
average cost of funds. The capitalized interest is included in the cost of the relevant asset and
is depreciated over the estimated useful life of the asset.
l) Intangible assets
Intangible assets consist of goodwill representing the excess of purchase cost over the fair
value of the net tangible and identified intangible assets of businesses acquired, and other
acquired intangibles, which include core-technology rights, trademarks, customer related
intangibles, marketing rights, marketing know-how and non-compete arrangements. The acquisition of
product brands is recorded as purchase of intangible assets. The assets are recorded on the date
of acquisition at cost. Trademarks, core- technologies, marketing rights, marketing know-how,
customer related intangibles and non-compete arrangements are amortized over the expected benefit
period or the legal life, whichever is lower. Other intangible assets are amortized on the
straight-line method over the period during which the benefits are expected to accrue from these
assets. Such periods are as follows:
F-11
DR. REDDYS LABORATORIES LIMITED AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(in thousands, except share data and where otherwise stated)
2. Significant accounting policies (continued)
|
|
|
Goodwill
|
|
Tested for impairment at least annually |
Trademarks
|
|
5 to 10 years |
Core technology rights and licenses
|
|
10 to 15 years |
Marketing rights
|
|
11 to 16 years |
Non-compete arrangements
|
|
1.5 to 10 years |
Marketing know-how
|
|
6 months |
Customer-related intangibles
|
|
5 years |
m) Impairment or disposal of long-lived assets and long-lived assets to be disposed of
Long-lived assets and finite life intangibles are reviewed for impairment whenever events or
changes in business circumstances indicate that the carrying amount of assets may not be fully
recoverable. Each impairment test is based on a comparison of the undiscounted cash flows expected
to be generated from the use of the asset to its recorded value. If impairment is indicated, the
asset is written down to its fair value. Long-lived assets to be disposed are reported at the lower
of the carrying value or fair value, less cost to sell.
n) Start-up costs
Costs of start-up activities including organization costs are expensed as incurred.
o) Research and development
Research and development cost is expensed as incurred. In-process technologies used in
research and development projects and having no alternate future uses are expensed upon purchase.
Capital expenditure incurred on equipment and facilities acquired or constructed for research and
development activities and having alternative future uses, is capitalized as property, plant and
equipment when acquired or constructed.
p) Foreign currency transactions
Foreign currency transactions are converted into Indian rupees at the rates of exchange
prevailing on the date of the respective transactions. Assets and liabilities in foreign currency
are converted into Indian rupees at the exchange rate prevailing on the balance sheet date. The
resulting exchange gains/losses are included in the statement of income. For entities that operate
in a highly inflationary economy, the functional currency is determined as the Indian Rupee.
q) Stock-based compensation
The Company uses the Black-Scholes option pricing model to determine the fair value of each
option grant. The Black-Scholes model includes assumptions regarding dividend yields, expected
volatility, expected lives and risk free interest rates. These assumptions reflect managements
best estimates, but these assumptions involve inherent market uncertainties based on market
conditions generally outside of the control of the Company. As a result, if other assumptions had
been used in the current period, stock-based compensation expense could have been materially
impacted. Furthermore, if management uses different assumptions in future periods, stock based
compensation expense could be materially impacted in future years.
F-12
DR. REDDYS LABORATORIES LIMITED AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(in thousands, except share data and where otherwise stated)
2. Significant accounting policies (continued)
The fair value of each option is estimated on the date of grant using the Black-Scholes model with
the following assumptions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended March 31, |
|
|
2003 |
|
2004 |
|
2005 |
Dividend yield |
|
|
0.4 |
% |
|
|
0.5 |
% |
|
|
0.5 |
% |
Expected life |
|
42-78 months |
|
42-78 months |
|
12-78 months |
Risk free interest rates |
|
|
5.8 - 6.8 |
% |
|
|
5.2 - 6.8 |
% |
|
|
4.5-6.7 |
% |
Volatility |
|
|
49.8 - 50.7 |
% |
|
|
45.7-50.7 |
% |
|
|
39.4-44.6 |
% |
At March 31, 2005, the Company had three stock-based employee compensation plans, which are
described more fully in Note 21. Prior to April 1, 2003, the Company accounted for its plans under
the recognition and measurement provisions of APB Opinion No. 25, Accounting for Stock Issued to
Employees, and related interpretations. No stock-based employee compensation cost was reflected in
previously reported results, as all options granted under those plans had an exercise price equal
to the market value of the underlying common stock on the date of grant. During the first quarter
of fiscal 2004, the Company adopted the fair value recognition provisions of SFAS No. 123,
Accounting for Stock- Based Compensation, for stock-based employee compensation. The Company has
selected the retroactive method of adoption described in SFAS No. 148 Accounting for Stock Based
Compensation Transition and Disclosure for all options granted after January 1, 1995.
Consequently, for the years ended March 31, 2003, 2004 and 2005, an amount of Rs.128,483,
Rs.122,177 and Rs.144,001 respectively, has been recorded as total employee stock based
compensation expense.
During fiscal 2004 , Aurigene Discovery Technologies Limited adopted two stock based employee
compensation plans, which are described more fully in Note 21. The Company has accounted for these
plans under SFAS 123, using the Black Scholes option pricing model to determine the fair value of
each option grant.
r) Income taxes
Income taxes are accounted for using the asset and liability method. Deferred tax assets and
liabilities are recognized for the future tax consequences attributable to differences between the
financial statement carrying amounts of existing assets and liabilities and their respective tax
bases and operating loss carry-forwards. Deferred tax assets and liabilities are measured using
enacted tax rates expected to apply to taxable income in the years in which those temporary
differences are expected to be recovered or settled. The effect on deferred tax assets and
liabilities of a change in tax rates is recognized in the statement of operations in the period
that includes the enactment date. The measurement of deferred tax assets is reduced, if necessary,
by a valuation allowance for any tax benefits the future realization of which is not considered
more likely than not.
s) Earnings per share
In accordance with SFAS No.128, Earnings per Share, basic earnings per share is computed using
the weighted average number of common shares outstanding during the period. Diluted earnings per
share is computed using the weighted average number of common and dilutive common equivalent shares
outstanding during the period, using the treasury stock method for options and warrants, except
where the results would be anti-dilutive.
t) Reclassifications
Certain items aggregating to Rs.340,970, Rs.131,085 and Rs.202,804 for the years ended March
31, 2003, 2004 and 2005 respectively were presented as Other operating income, net in the annual
report to the stockholders for fiscal 2005. These items have been presented under Other
(expense)/income, net in the consolidated financial statements presented herein. As a result,
Other operating income, net, Total operating expenses, net, Operating income/(loss) and
Other (expense)/income, net as reported and as presented herein has changed as set out below:
F-13
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As reported in annual report to stockholders |
|
As presented herein |
|
|
Year ended March 31, |
|
Year ended March 31, |
|
|
2003 |
|
2004 |
|
2005 |
|
2003 |
|
2004 |
|
2005 |
Other operating income,net |
|
Rs. |
340,970 |
|
|
Rs. |
131,085 |
|
|
Rs. |
202,804 |
|
|
Rs. |
|
|
|
Rs. |
|
|
|
Rs. |
|
|
Total operating
expenses,net |
|
|
6,663,628 |
|
|
|
8,523,838 |
|
|
|
10,249,751 |
|
|
|
7,004,598 |
|
|
|
8,654,923 |
|
|
|
10,452,555 |
|
Operating income/(loss) |
|
|
3,558,611 |
|
|
|
2,211,294 |
|
|
|
(163,646 |
) |
|
|
3,217,641 |
|
|
|
2,080,209 |
|
|
|
(366,450 |
) |
Other (expense)/income,net |
|
|
342,154 |
|
|
|
373,106 |
|
|
|
328,776 |
|
|
|
683,124 |
|
|
|
504,191 |
|
|
|
531,580 |
|
F-14
DR. REDDYS LABORATORIES LIMITED AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(in thousands, except share data and where otherwise stated)
2. Significant accounting policies (continued)
u) Recent accounting pronouncements
In November 2004, the FASB issued SFAS No. 151, Amendment of Accounting Research Bulletin
(ARB) No. 43, Chapter 4 on Inventory Costs. SFAS 151 amends and clarifies financial accounting
and reporting for inventory costs. SFAS 151 is effective for inventory costs incurred during
fiscal years beginning after June 15, 2005. The Company is evaluating the impact of adoption of
SFAS 151 on its consolidated financial statements.
In December 2004, the FASB issued SFAS No. 123 (revised 2004), Share-Based Payment (SFAS
123R). SFAS 123R is an amendment of FASB statement No. 123, Accounting for Stock-Based
Compensation. This statement also supersedes APB Opinion No. 25, Accounting for Stock Issued to
Employees. SFAS 123R focuses primarily on accounting for transactions in which an entity obtains
employee services in share-based payment transactions. Pursuant to the Securities and Exchange
Commission Release No. 33-8568, the Company is required to adopt SFAS 123R from April 1, 2006.
Adoption of SFAS No. 123R will not have any material impact on the consolidated financial
statements, as the Company has already adopted fair value accounting under SFAS 123.
F-15
DR. REDDYS LABORATORIES LIMITED AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(in thousands, except share data and where otherwise stated)
3. Business combinations
Dr. Reddys Laboratories Inc.
In March 2000, DRLI, a consolidated subsidiary, acquired 25% of its common stock held by a
minority shareholder, for a cash consideration of Rs.1,072. This acquisition has been accounted
for by the purchase method. The acquisition resulted in goodwill of Rs.1,072. The terms of the
purchase also provide for contingent consideration not exceeding U.S.$14,000 over the next ten
years based on achievement of certain specified targets. Such payments would be recorded as
goodwill in the periods in which the contingency is resolved in accordance with the consensus
reached by the Emerging Issues Task Force on Issue 95-8, Accounting for Contingent Consideration
Paid to the Shareholders of an Acquired Enterprise in a Purchase Business Combination. During the
years ended March 31, 2004 and 2005, as certain specified targets have been met, DRLI has
paid/accrued Rs.53,837 (U.S.$1,180) and Rs.38,950 (U.S.$880 ) which has been recorded as goodwill.
Dr. Reddys Laboratories (EU) Limited
On April 11, 2002, the Company acquired the entire share capital of DRL EU (formerly BMS
Laboratories Limited) and its consolidated subsidiary, DRL U.K. (formerly Meridian Healthcare
Limited), for a total consideration of Rs.644,413 (U.K. pounds sterling 9,160). The purchase
consideration consists of:
|
|
|
|
|
Cash |
|
Rs. |
438,216 |
|
Loan notes |
|
|
128,108 |
|
Direct acquisition costs |
|
|
7,739 |
|
|
|
|
|
|
|
|
|
574,063 |
|
Contingent consideration |
|
|
70,350 |
|
|
|
|
|
|
|
|
Rs. |
644,413 |
|
|
|
|
|
|
At the date of acquisition, the Company recorded the cost of the acquisition as Rs.574,063,
consisting of the cash paid, loan notes issued, and the direct acquisition costs. The agreement
includes the payment of a contingent consideration amounting up to Rs.70,350, which is held in an
escrow account. This amount is subject to set-off for certain indemnity claims in respect of legal
and tax matters that may arise, pertaining to the periods prior to the acquisition. Therefore,
this amount has not been included in the determination of the cost of acquisition initially, and
the amount which has not been adjusted to the contingency will be included as purchase
consideration upon expiration of the escrow period in 2007. As per the agreement, an amount of
Rs.9,453 (U.K. pounds sterling 123 ) was released to the sellers from escrow during fiscal 2004,
which was treated as goodwill.
DRL EU and DRL U.K. are U.K. based pharmaceutical companies engaged in the manufacture and
marketing of generic pharmaceuticals. As a result of the acquisition, DRL has gained entry into
the U.K. generics market. The Company has accounted for the acquisition under the purchase
method. Accordingly, the financial results for the period subsequent to April 11, 2002 have been
included in the consolidated financial statements of the Company. The purchase cost of Rs.574,063
has been allocated as follows:
F-16
DR. REDDYS LABORATORIES LIMITED AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(in thousands, except share data and where otherwise stated)
3. Business combinations (continued)
|
|
|
|
|
Current assets |
|
|
|
|
Cash |
|
Rs. |
98,271 |
|
Other current assets |
|
|
269,477 |
|
Property, plant and equipment |
|
|
109,811 |
|
Intangibles |
|
|
|
|
Goodwill |
|
|
10,217 |
|
Trademarks |
|
|
153,189 |
|
Customer-related intangibles |
|
|
106,946 |
|
Non-compete arrangements |
|
|
26,736 |
|
Other intangibles |
|
|
6,859 |
|
Other assets |
|
|
2,327 |
|
|
|
|
|
|
Total assets |
|
|
783,833 |
|
Liabilities assumed |
|
|
(141,116 |
) |
Deferred tax liability |
|
|
(68,654 |
) |
|
|
|
|
|
Purchase cost |
|
Rs. |
574,063 |
|
|
|
|
|
|
Customer related intangibles represent the fair value of the existing customer lists of the
acquired companies. The estimated useful life of all the intangibles is 5 years other than
operating leases which are amortized over 4 years.
Reddy US Therapeutics, Inc. (Reddy US)
During the year ended March 31, 2004, the Company, through its wholly owned subsidiary,
acquired the balance (10.2%) of the common stock of Reddy US held by a minority shareholder in
exchange for issuing 70,000 American Depositary Shares (ADS) of the Company to such minority
shareholder (representing an exchange ratio of 7 ADS for every 100 shares of Reddy US common stock
acquired). This acquisition was accounted for by the purchase method. The acquisition has resulted
in goodwill of Rs.90,437.
4.
Acquisition of Trigenesis Therapeutics Inc.
On April 27, 2004, the Company acquired the entire share capital of Trigenesis Therapeutics
Inc. (Trigenesis) for a total consideration of Rs.496,715 (U.S.$11,000).
Trigenesis is a U.S. based research company specializing in dermatology field. As a result of
the acquisition, DRL has acquired certain technology platforms and marketing rights. The
acquisition has been accounted for as a purchase of intangible assets as Trigenesis did not meet
the definition of a business as described in EITF Issue No. 98-3, and accordingly the transaction
did not meet the definition of a business combination.
The total purchase consideration has been allocated to the acquired assets as of March 31,
2005 based on the valuation carried out by an independent valuer.
|
|
|
|
|
Core-technology rights and licenses |
|
Rs. |
132,753 |
|
Marketing rights |
|
Rs. |
86,619 |
|
In-process technology |
|
Rs. |
277,343 |
|
The Company has expensed off the amount allocated towards in-process technology being research and
development projects having no future alternate uses as research and development expenses. The
core-technology rights and licenses and marketing rights have been capitalized as intangible assets
to be amortized over the period over which the intangible assets are expected to contribute
directly or indirectly to the future cash flows.
F-17
DR. REDDYS LABORATORIES LIMITED AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(in thousands, except share data and where otherwise stated)
5. Goodwill and intangible assets
On April 1, 2002, the Company adopted SFAS No. 142, Goodwill and Other Intangible Assets.
Adoption of SFAS No. 142 did not result in reclassification of existing goodwill and intangible
assets.
As required by SFAS No. 142, the Company identified its reporting units and assigned assets
and liabilities, including goodwill to the reporting units on the date of adoption. Subsequently,
the Company compared the fair value of the reporting unit to its carrying value including goodwill,
to determine whether goodwill is impaired at the date of adoption. This transitional impairment
evaluation did not indicate an impairment loss.
Subsequent to the adoption of SFAS No.142, the Company does not amortize goodwill but tests
goodwill for impairment at least annually. The carrying value of the goodwill (including the
goodwill arising on investment in affiliate of Rs.181,943) and net other intangible assets on the
date of adoption was Rs.1,473,605 and Rs.1,276,397 respectively.
Trademarks, marketing know-how, customer related intangibles and non-compete arrangements are
amortized over the expected benefit period or the legal life, whichever is lower.
F-18
DR. REDDYS LABORATORIES LIMITED AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(in thousands, except share data and where otherwise stated)
5. Goodwill and intangible assets (continued)
The following table presents the changes in goodwill during the year ended March 31, 2004 and
March 31, 2005:
|
|
|
|
|
|
|
|
|
|
|
Year ended March 31, |
|
|
2004 |
|
2005 |
Balance at the beginning of the period |
|
Rs. |
1,550,419 |
|
|
Rs. |
1,704,492 |
|
Acquired during the period |
|
|
154,073 |
|
|
|
38,950 |
|
|
|
|
|
|
|
|
|
|
Balance at the end of the period |
|
Rs. |
1,704,492 |
|
|
Rs. |
1,743,442 |
|
|
|
|
|
|
|
|
|
|
The following table presents acquired and amortized intangible assets as at March 31,
2004 and 2005:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of March 31, 2004 |
|
As of March 31, 2005 |
|
|
Gross carrying |
|
Accumulated |
|
Gross carrying |
|
Accumulated |
|
|
amount |
|
amortization |
|
amount |
|
amortization |
|
|
|
Trademarks |
|
Rs. |
2,565,733 |
|
|
Rs. |
1,519,357 |
|
|
Rs. |
2,570,242 |
|
|
Rs. |
1,833,303 |
|
Core-technology
rights |
|
|
|
|
|
|
|
|
|
|
132,753 |
|
|
|
|
|
Non-compete arrangements |
|
|
110,624 |
|
|
|
92,082 |
|
|
|
111,289 |
|
|
|
98,602 |
|
Marketing know-how |
|
|
80,000 |
|
|
|
80,000 |
|
|
|
80,000 |
|
|
|
80,000 |
|
Marketing rights |
|
|
|
|
|
|
|
|
|
|
94,852 |
|
|
|
3,659 |
|
Customer related intangibles |
|
|
122,497 |
|
|
|
48,328 |
|
|
|
125,156 |
|
|
|
73,908 |
|
Others |
|
|
7,857 |
|
|
|
3,874 |
|
|
|
8,027 |
|
|
|
5,965 |
|
|
|
|
|
|
Rs. |
2,886,711 |
|
|
Rs. |
1,743,641 |
|
|
Rs. |
3,122,319 |
|
|
Rs. |
2,095,437 |
|
|
|
|
The aggregate amortization expense for the years ended March 31, 2003, 2004 and 2005 was
Rs.419,439, Rs.382,857 and Rs.349,991 respectively.
Estimated amortization expense for the next five years with respect to such assets is as
follows:
|
|
|
|
|
For the year ended March 31, |
|
|
|
|
2006 |
|
|
311,381 |
|
2007 |
|
|
283,659 |
|
2008 |
|
|
197,024 |
|
2009 |
|
|
69,430 |
|
2010 |
|
|
18,907 |
|
Thereafter |
|
|
146,481 |
|
|
|
|
|
|
Total |
|
|
1,026,882 |
|
|
|
|
|
|
F-19
DR. REDDYS LABORATORIES LIMITED AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(in thousands, except share data and where otherwise stated)
5. Goodwill and intangible assets (continued)
The intangible assets (net of amortization) as of March 31, 2005 have been allocated to the
following segments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Active |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pharmaceutical |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ingredients and |
|
|
|
|
|
Drug |
|
|
|
|
Formulations |
|
Intermediates |
|
Generics |
|
Discovery |
|
Total |
Goodwill |
|
Rs. |
349,774 |
|
|
Rs. |
997,025 |
|
|
Rs. |
306,206 |
|
|
Rs. |
90,437 |
|
|
Rs. |
1,743,442 |
|
Trademarks |
|
|
647,369 |
|
|
|
|
|
|
|
89,570 |
|
|
|
|
|
|
|
736,939 |
|
Core-technology rights |
|
|
|
|
|
|
|
|
|
|
132,753 |
|
|
|
|
|
|
|
132,753 |
|
Non-compete arrangements |
|
|
|
|
|
|
|
|
|
|
12,687 |
|
|
|
|
|
|
|
12,687 |
|
Customer related intangibles |
|
|
|
|
|
|
|
|
|
|
51,248 |
|
|
|
|
|
|
|
51,248 |
|
Marketing rights |
|
|
|
|
|
|
|
|
|
|
91,193 |
|
|
|
|
|
|
|
91,193 |
|
Others |
|
|
|
|
|
|
|
|
|
|
2,062 |
|
|
|
|
|
|
|
2,062 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rs. |
997,143 |
|
|
Rs. |
997,025 |
|
|
Rs. |
685,719 |
|
|
Rs. |
90,437 |
|
|
Rs. |
2,770,324 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The intangible assets (net of amortization) as of March 31, 2004 have been allocated to
the following segments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Active |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pharmaceutical |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ingredients and |
|
|
|
|
|
Drug |
|
|
|
|
Formulations |
|
Intermediates |
|
Generics |
|
Discovery |
|
Total |
Goodwill |
|
Rs. |
349,774 |
|
|
Rs. |
997,025 |
|
|
Rs. |
267,256 |
|
|
Rs. |
90,437 |
|
|
Rs. |
1,704,492 |
|
Trademarks |
|
|
915,295 |
|
|
|
|
|
|
|
131,081 |
|
|
|
|
|
|
|
1,046,376 |
|
Non-compete arrangements |
|
|
|
|
|
|
|
|
|
|
18,542 |
|
|
|
|
|
|
|
18,542 |
|
Customer related intangibles |
|
|
|
|
|
|
|
|
|
|
74,169 |
|
|
|
|
|
|
|
74,169 |
|
Others |
|
|
|
|
|
|
|
|
|
|
3,983 |
|
|
|
|
|
|
|
3,983 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rs. |
1,265,069 |
|
|
Rs. |
997,025 |
|
|
Rs. |
495,031 |
|
|
Rs. |
90,437 |
|
|
Rs. |
2,847,562 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-20
DR. REDDYS LABORATORIES LIMITED AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(in thousands, except share data and where otherwise stated)
6. Cash, cash equivalents and restricted cash
Cash and cash equivalents comprise cash and cash on deposit placed with banks in the normal
course of business operations. Restricted cash represents margin money deposits against guarantees
and letters of credit. Restrictions on such deposits are released on the expiration of the terms
of guarantee and letters of credit.
7. Accounts receivable
The accounts receivable as of March 31, 2004 and 2005 are stated net of allowance for
doubtful accounts. The Company maintains an allowance for doubtful accounts on all accounts
receivable, including receivables sold with recourse, based on present and prospective financial
condition of the customer and ageing of the accounts receivable after considering historical
experience and the current economic environment. Accounts receivable are generally not
collateralized.
The activity in the allowance for doubtful accounts receivable is given below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended March 31, |
|
|
2003 |
|
2004 |
|
2005 |
Balance at the beginning of the year |
|
Rs. |
151,215 |
|
|
Rs. |
141,949 |
|
|
Rs. |
139,569 |
|
Additional provision |
|
|
93,883 |
|
|
|
19,871 |
|
|
|
79,442 |
|
Bad debts charged to provision |
|
|
(103,149 |
) |
|
|
(22,251 |
) |
|
|
(47,857 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at the end of the year |
|
Rs. |
141,949 |
|
|
Rs. |
139,569 |
|
|
Rs. |
171,154 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8. Inventories
Inventories consist of the following:
|
|
|
|
|
|
|
|
|
|
|
As of March 31, |
|
|
2004 |
|
2005 |
Raw materials |
|
Rs. |
907,855 |
|
|
Rs. |
1,008,729 |
|
Stores and spares |
|
|
262,461 |
|
|
|
316,915 |
|
Work-in-process |
|
|
987,318 |
|
|
|
1,068,115 |
|
Finished goods |
|
|
874,017 |
|
|
|
1,105,847 |
|
|
|
|
|
|
|
|
|
|
|
|
Rs. |
3,031,651 |
|
|
Rs. |
3,499,606 |
|
|
|
|
|
|
|
|
|
|
During the years ended March 31, 2003, 2004 and 2005 the Company recorded an inventory
write-down of Rs.34,239, Rs.31,898 and Rs.52,692 respectively, resulting from a decline in the
market value of certain finished goods and write down of certain raw materials and these amounts
are included in the cost of goods sold.
9. Other assets
Other assets consist of the following:
|
|
|
|
|
|
|
|
|
|
|
As of March 31, |
|
|
2004 |
|
2005 |
Prepaid expenses |
|
Rs. |
229,336 |
|
|
Rs. |
124,972 |
|
Advances to suppliers |
|
|
229,941 |
|
|
|
135,352 |
|
Balances with statutory authorities |
|
|
209,944 |
|
|
|
193,806 |
|
Deposits |
|
|
87,827 |
|
|
|
99,896 |
|
Others |
|
|
1,045,349 |
|
|
|
908,998 |
|
|
|
|
|
|
|
|
|
|
|
|
|
1,802,397 |
|
|
|
1,463,024 |
|
Less: Current assets |
|
|
1,712,864 |
|
|
|
1,361,578 |
|
|
|
|
|
|
|
|
|
|
|
|
Rs. |
89,533 |
|
|
Rs. |
101,446 |
|
|
|
|
|
|
|
|
|
|
Balances with the statutory authorities represent amounts deposited with the excise
authorities and the unutilized excise input credits on purchases. These are regularly utilized to
offset the excise liability on the goods produced. Accordingly, these balances have been
classified as current assets.
F-21
DR. REDDYS LABORATORIES LIMITED AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(in thousands, except share data and where otherwise stated)
9. Other assets (continued)
Deposits mainly comprise telephone, premises and other deposits. Others mainly represents
receivables of duties and income tax deducted at source on interest received by the Company.
10. Property, plant and equipment, net
Property, plant and equipment consist of the following:
|
|
|
|
|
|
|
|
|
|
|
As of March 31, |
|
|
2004 |
|
2005 |
Land |
|
Rs. |
443,829 |
|
|
Rs. |
519,902 |
|
Buildings |
|
|
1,737,594 |
|
|
|
2,064,956 |
|
Plant and machinery |
|
|
5,504,888 |
|
|
|
6,947,490 |
|
Furniture, fixtures and equipment |
|
|
648,935 |
|
|
|
734,721 |
|
Vehicles |
|
|
175,166 |
|
|
|
238,556 |
|
Computer equipment |
|
|
352,615 |
|
|
|
429,266 |
|
Capital work-in-progress |
|
|
1,008,076 |
|
|
|
567,974 |
|
|
|
|
|
|
|
|
|
|
|
|
|
9,871,103 |
|
|
|
11,502,865 |
|
Accumulated depreciation and amortization |
|
|
(3,539,968 |
) |
|
|
(4,444,557 |
) |
|
|
|
|
|
|
|
|
|
|
|
Rs. |
6,331,135 |
|
|
Rs. |
7,058,308 |
|
|
|
|
|
|
|
|
|
|
Depreciation expense for the years ended March 31, 2003, 2004 and 2005 was Rs.598,374,
Rs.745,596 and Rs.959,299 respectively.
11. Investment securities
Investment securities consist of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of March 31, 2004 |
|
As of March 31, 2005 |
|
|
|
|
|
|
Gross |
|
Gross |
|
|
|
|
|
|
|
|
|
Gross |
|
Gross |
|
|
|
|
|
|
|
|
unrealized |
|
Unrealized |
|
|
|
|
|
|
|
|
|
Unrealized |
|
Unrealized |
|
|
|
|
Carrying |
|
holding |
|
Holding |
|
|
|
|
|
Carrying |
|
Holding |
|
Holding |
|
|
|
|
Value |
|
gains |
|
Losses |
|
Fair Value |
|
Value |
|
Gains |
|
Losses |
|
Fair Value |
Equity securities |
|
Rs. |
4,692 |
|
|
Rs. |
8,292 |
|
|
Rs. |
(49 |
) |
|
Rs. |
12,935 |
|
|
Rs. |
3,096 |
|
|
Rs. |
4,787 |
|
|
|
|
|
|
Rs. |
7,883 |
|
Debt securities |
|
|
1,537,312 |
|
|
|
10,900 |
|
|
|
|
|
|
|
1,548,212 |
|
|
|
1,009,785 |
|
|
|
|
|
|
|
(24,965 |
) |
|
|
984,820 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,542,004 |
|
|
|
19,192 |
|
|
|
(49 |
) |
|
|
1,561,147 |
|
|
|
1,012,881 |
|
|
|
4,787 |
|
|
|
(24,965 |
) |
|
|
992,703 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-marketable
equity securities |
|
|
2,728 |
|
|
|
|
|
|
|
|
|
|
|
2,728 |
|
|
|
2,728 |
|
|
|
|
|
|
|
|
|
|
|
2,728 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rs. |
1,544,732 |
|
|
Rs. |
19,192 |
|
|
Rs. |
(49 |
) |
|
Rs. |
1,563,875 |
|
|
Rs. |
1,015,609 |
|
|
|
4,787 |
|
|
|
(24,965 |
) |
|
Rs. |
995,431 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
Mutual Funds |
|
|
2,536,223 |
|
|
|
|
|
|
|
|
|
|
|
2,536,223 |
|
|
|
300,000 |
|
|
|
10,887 |
|
|
|
|
|
|
|
310,887 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rs. |
2,536,223 |
|
|
|
|
|
|
|
|
|
|
Rs. |
2,536,223 |
|
|
Rs. |
300,000 |
|
|
Rs. |
10,887 |
|
|
|
|
|
|
Rs. |
310,887 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Debt securities as of March 31, 2004 mature between one through five years. Dividends
from equity securities available for sale, during the years ended March 31, 2003, 2004 and 2005
were Rs.175, Rs.53 and Rs.98 respectively, and are included in other income.
F-22
DR. REDDYS LABORATORIES LIMITED AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(in thousands, except share data and where otherwise stated)
11. Investment securities (continued)
Gain on sale of mutual funds during the years ended March 31, 2003, 2004 and 2005 was
Rs.6,284, Rs.24,786 and Rs.64,997 respectively. Proceeds from sale of available for sale
securities were Rs.2,939,603, Rs.9,167,150 and Rs.13,079,463 during the years ended March 31, 2003,
2004 and 2005 respectively.
12. Operating leases
The Company leases office and residential facilities under operating lease agreements that are
renewable on a periodic basis at the option of both the lessor and the lessee. Rental expense
under those leases was Rs.80,627, Rs.101,845 and Rs.198,692 for the years ended March 31, 2003,
2004 and 2005 respectively.
The schedule of future minimum rentals payments in respect of non-cancellable operating leases
is set out below:
|
|
|
|
|
Year ended March 31, |
|
|
|
|
2006 |
|
|
74,546 |
|
2007 |
|
|
74,926 |
|
2008 |
|
|
74,897 |
|
2009 |
|
|
69,652 |
|
2010 |
|
|
69,888 |
|
Thereafter |
|
|
227,300 |
|
|
|
|
|
|
|
|
|
591,209 |
|
|
|
|
|
|
13. Investment in affiliates
Compact Electric Limited: During the year ended March 31, 2004, the Company sold a 51% equity
stake in its wholly owned subsidiary. In accordance with the sale agreement the Company intended to
divest the balance of its 49% equity holding in a phased manner over the next two years at an
agreed price. Pursuant to such sale, the Company relinquished control and exercised significant
influence over the operations of Compact Electric Limited through its remaining 49% equity stake.
The Company as of March 31, 2004 also received an interest free deposit of Rs.53,000 towards the
preference share holding pending receipt of necessary regulatory approvals.
During the year ended March 31, 2005, the Company, entered into an amended sale agreement and
has sold the balance of 49% equity stake in its wholly owned subsidiary at an agreed price of
Rs.82,000, including its preference shares. During the year the Company also received the necessary
regulatory approvals for conversion of its preference holdings to a loan consequent to which, the
interest free deposit has since been adjusted, with Companys loan. Accordingly, the carrying value
of the Companys investment in Compact Electric Limited as of March 31, 2004 and 2005 is Rs.90,122
and Rs. Nil respectively.
Reddy Kunshan: Reddy Kunshan is engaged in manufacturing and marketing of active
pharmaceutical ingredients and intermediates and formulations in China. During the year ended March
31, 2002, the Company acquired an additional 4.9% interest in Reddy Kunshan for a cash
consideration of Rs.47,532. Consequently, the Companys interest in Reddy Kunshan increased to
51%.
Three of the directors of the Company are on the board of directors of Reddy Kunshan, which
comprises seven directors. Under the terms of the agreement, all decisions with respect to
operating activities, significant financing and other activities are taken by the majority approval
of at least five of the seven directors of the board. These significant decisions include
amendments to the Articles, suspensions of the operations, alterations to the registered capital
etc. As the Company does not have the control over the board and as the other partners have
significant participating rights, acting on its own, the Company will not be in a position to
control or take any significant operating decisions of Reddy Kunshan and would require approval of
other shareholders. Therefore, the Company has accounted for its interest by the equity method.
During the year ended March 31, 2005 the Company further invested Rs.49,935 along with one of
its other joint venture partners in Reddy Kunshan. Consequently, the Companys interest in Reddy
Kunshan increased to 51.2%.
F-23
The Companys equity in the loss of Reddy Kunshan for the years ended March 31, 2003, 2004 and
2005 was Rs.66,177 Rs.44,362 and Rs.58,101 respectively. The carrying value of the investment in
Reddy Kunshan as of March 31, 2004 and 2005 was Rs.189,060 and Rs.180,894 respectively
F-24
DR. REDDYS LABORATORIES LIMITED AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(in thousands, except share data and where otherwise stated)
13. Investment in affiliates (continued)
Pathnet: Pathnet is engaged in the business of setting up medical pathology laboratories. The
Company acquired a 49% interest in Pathnet on March 1, 2001 for a consideration of Rs.4,000.
During the year ended March 31, 2002 the Company further invested Rs.60,310. The Company has
accounted for its 49% interest in Pathnet by the equity method. The Companys equity in the loss
of Pathnet for the years ended March 31, 2003, 2004 and 2005 was Rs.25,917, Rs.Nil and Rs.Nil
respectively. The carrying value of the investment in Pathnet as of March 31, 2004 and 2005 was
Rs.Nil and Rs.Nil respectively.
14. Variable interest entities
On January 30, 2004, the Company along with two individuals formed APR LLC, a Delaware limited
liability company. APR, LLC is a development stage enterprise, which is in the process of
developing an active pharmaceutical ingredient (API). Equity capital of APR, LLC consists of
Class A equity interests, which are held by two individuals and Class B equity interests held by
DRL. The initial contribution for the Class A interests was U.S.$400 (Rs.17,487) in cash. Class A
interests carry voting rights and participate in the profits and losses of APR, LLC in the normal
course of business. DRL contributed U.S.$500 (Rs.21,859) in cash for its Class B interests, which
was used to acquire intellectual property rights. Class B interests carry certain protective
rights only.
Further, DRL has entered into a development and supply agreement under which DRL and APR will
collaborate in the development, marketing and sale of API and generic dosages. Under the terms of
the agreement, DRL is committed to fund the entire research and development of API. This amount is
repayable upon successful commercialization of the product. Under this agreement, the Company has
paid U.S.$670 (Rs.29,291) as of March 31, 2004. During the year ended March 31, 2005 the Company
has further paid U.S.$1,146 (Rs.49,209) to fund ongoing research and development.
The Company has evaluated this transaction and believes that APR meets the criteria to be a
variable interest entity and that the Company, being the primary beneficiary, is required to
consolidate APR under the requirements of FIN 46R. Accordingly, on January 30, 2004, the Company
recorded the assets, liabilities and the non-controlling interest at a fair value of U.S.$900
(Rs.39,346).
15. Financial instruments and concentration of risk
Concentration of risk: Financial instruments that potentially subject the Company to
concentrations of credit risk consist principally of cash equivalents, accounts receivable,
investment securities and marketable securities. The Companys cash resources are invested with
financial institutions and commercial corporations with high investment grade credit ratings.
Limits have been established by the Company as to the maximum amount of cash that may be invested
with any such single entity. To reduce credit risk, the Company performs ongoing credit
evaluations of customers.
Pursuant to the terms of an agreement with Par Pharmaceuticals Inc. (PAR), the Company
supplies certain generic formulations to PAR for further sale to customers in the United States.
Under this arrangement the Company sells its products to PAR at an agreed price. Subsequently, PAR
remits additional amount upon further sales made by it to the end customer. As of March 31, 2004
and 2005, receivables from PAR under this arrangement aggregated to Rs.415,857 and Rs.210,463
representing 11.1% and 5.9% of the total receivables and revenues during the years ended March 31,
2003, 2004 and 2005 aggregated to Rs.3,506,874, Rs.3,224,647 and Rs.1,638,939, representing 19.4%,
16.1% and 8.4% of the total revenues of the Company.
Derivative financial instruments. The Company enters into certain forward foreign exchange
contracts and certain derivative arrangements where the counterparty is generally a bank. The
Company does not consider the risk of non-performance by the counterparty to be significant.
F-25
DR. REDDYS LABORATORIES LIMITED AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(in thousands, except share data and where otherwise stated)
15. Financial instruments and concentration of risk (continued)
The following table presents the aggregate contracted principal amounts of the Companys
derivative financial instruments outstanding:
|
|
|
|
|
|
|
|
|
|
|
As of March 31, |
|
|
2004 |
|
2005 |
Forward exchange contracts (USD-INR) (sell) |
|
U.S.$ |
78,000 |
|
|
U.S.$ |
30,000 |
|
Forward exchange contracts (USD-INR) (buy) |
|
|
|
|
|
U.S.$ |
40,000 |
|
Forward exchange contracts (GBP/USD) |
|
|
|
|
|
GBP2,000 |
|
Option contracts (USD/INR) |
|
U.S.$ |
15,000 |
|
|
|
|
|
Cross currency option contracts (GBP/USD) |
|
GBP6,000 |
|
|
|
|
|
Interest rate swap options |
|
Rs. |
2,500,000 |
|
|
|
|
|
The foreign forward exchange contracts mature between one to two months.
16. Research and development arrangement
The Company undertakes significant portion of the research and development activities relating
to drug discovery through its research facilities located in the United States and India. The
Company under an existing arrangement also undertakes research and development activities through
the Research Foundation, a special purpose entity, organized as a trust to avail certain tax
benefits under the Indian Income Tax Rules. At present, the Research Foundation does not undertake
research and development activity for any other entity. The operations of the Research Foundation
are funded by the Company and as a result this entity has been consolidated in the financial
statements. The Company has the first right to use the intellectual property rights relating to
patents, copyrights, trademarks and know-how discovered or developed by the Research Foundation.
During the year ended 31 March 2005, the Company entered into a joint development and
commercialization agreement with I-VEN Pharma Capital Limited (I-VEN). As per the terms of the
agreement, I-VEN will fund up to fifty percent of the project costs (development, registration and
legal costs) related to these products and the filings made by the Company for the United States of
America market. The terms of the arrangement do not require the Company to repay the funds or
purchase I-VENs interest in the event of the failure of the research and development. However,
upon successful commercialization of these products, the Company will pay I-VEN a royalty on net
sales for a period of 5 years for each product. The first tranche advanced by I-VEN of Rs.985,388
was received on March 28, 2005. I-VEN has an option to further invest U.S.$33.5 million
(Rs.1,465,458) by March 31, 2006.
The amount received from I-VEN will be recognized in the income statement as a credit to
research and development expenses upon completion of specific milestones as detailed in the
agreement. Accordingly, an amount of Rs.96,239 has been recognized in the current year representing
the proportionate costs relating to the completion of specified filings.
17. Borrowings from banks
The Company had a line of credit of Rs.3,234,000 and Rs.5,319,000 as of March 31, 2004 and
2005, from its bankers for working capital requirements. The line of credit is renewable annually.
The credit bears interest at the prime rate of the banks, which averaged 10.5% and 10.25% for
rupee borrowings and LIBOR+65 basis points for foreign currency borrowing during the years ended
March 31, 2004 and 2005 respectively. As of March 31, 2005, the Company had drawn down upon such
facilities, in amounts as foreign currency, for packing credit loans, cash credit and as temporary
overdraft facilities, all of which are repayable on demand. These borrowings, except for the
foreign currency packing credit loan, are secured by inventories, accounts receivable and certain
property. The facilities contain financial covenants and restrictions on indebtedness. The Company
has an option to draw down the balance of the line of credit based on its requirements.
F-26
DR. REDDYS LABORATORIES LIMITED AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(in thousands, except share data and where otherwise stated)
18. Long-term debt
Long-term debt consists of the following:
|
|
|
|
|
|
|
|
|
|
|
As of March 31, |
|
|
2004 |
|
2005 |
Rupee term loans |
|
Rs. |
36,985 |
|
|
Rs. |
31,065 |
|
Loan notes |
|
|
146,738 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
183,723 |
|
|
|
31,065 |
|
Less: Current portion |
|
|
(152,658 |
) |
|
|
(5,920 |
) |
|
|
|
|
|
|
|
|
|
Non-current portion |
|
Rs. |
31,065 |
|
|
Rs. |
25,145 |
|
|
|
|
|
|
|
|
|
|
Rupee term loans represents a loan from Indian Renewable Energy Development Agency Limited
which is secured by way of hypothecation of specific movable assets pertaining to the Companys
solar grid interactive power plant located in Bachupally, Hyderabad.
An interest rate profile of long-term debt is given below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended March 31, |
|
|
2003 |
|
2004 |
|
2005 |
Foreign currency loan notes |
|
|
|
4% |
|
|
4 |
% |
|
|
4.8 |
% |
Rupee term loans |
|
2.0% to 12.0% |
|
|
2 |
% |
|
|
2.0 |
% |
A maturity profile of the long-term debt outstanding is as follows:
|
|
|
|
|
Maturing in the year ending March 31: |
|
|
|
|
2006 |
|
|
5,920 |
|
2007 |
|
|
5,920 |
|
2008 |
|
|
5,920 |
|
2009 |
|
|
5,920 |
|
2010 |
|
|
1,465 |
|
Thereafter |
|
|
|
|
|
|
|
|
|
|
|
Rs. |
25,145 |
|
|
|
|
|
|
The fair value of outstanding payments on the Rupee term loans were Rs.26,660 and Rs.23,573
for the years ending March 31, 2004 and 2005.
19. Shareholders equity
Equity shares and dividend
The Company presently has only one class of equity shares. For all matters submitted to vote
in the shareholders meeting, every holder of equity shares, as reflected in the records of the
Company on the date of the shareholders meeting shall have one vote in respect of each share held.
Indian statutes mandate that the dividends shall be declared out of the distributable profits
only after the transfer of up to 10% of net income computed in accordance with current regulations
to a general reserve. Should the Company declare and pay dividends, such dividends will be paid in
Indian rupees to each holder of equity shares in proportion to the number of shares held by him to
the total equity shares outstanding as on that date. Indian statutes on foreign exchange govern
the remittance of dividend outside India.
F-27
DR. REDDYS LABORATORIES LIMITED AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(in thousands, except share data and where otherwise stated)
19. Shareholders equity (continued)
In the event of liquidation of the affairs of the Company, all preferential amounts, if any,
shall be discharged by the Company. The remaining assets of the Company, after such discharge,
shall be distributed to the holders of equity shares in proportion to the number of shares held by
them.
Dividends on common stock are recorded as a liability at the point of their approval by the
shareholders in the annual general meeting. The shareholders approved and the Company paid
dividends of Rs.191,290, Rs.431,598 and Rs.431,615 during the years ended March 31, 2003, 2004 and
2005 respectively. The dividend per share was Rs.2.50, Rs.5.00 and Rs.5.00. during the years ended
March 31, 2003, 2004 and 2005 respectively.
Public Offering in the United States of America
On April 11, 2001, the Company made a public offering of its American Depositary Shares (ADSs)
to international investors. The offering consisted of 13,225,000 ADSs representing 13,225,000
equity shares (adjusted for share split), at an offering price of U.S.$10.04 per ADS amounting to
Rs.5,782,725, net of expenses. The equity shares represented by the ADS carry equivalent rights
with respect to voting and dividends as the other equity shares. As a part of this offering,
8,602,152 equity shares of Rs.5 each allotted and outstanding against Global Depository Receipts
issued and outstanding have also been converted to American Depository Shares.
20. Deferred revenue
The Company had, pursuant to an agreement entered into with Novartis Pharma AG (Novartis),
agreed to provide Novartis with an exclusive license to develop, promote, distribute, market and
sell certain products to be further developed into drugs for the treatment of specified diseases.
Pursuant to the terms of the agreement, during the year ended March 31, 2002, the Company received
Rs.235,550 (U.S.$5,000) as an up-front license fee. As the up-front license fee did not represent
the culmination of a separate earning process, the up-front license fee had been deferred to be
recognized in accordance with the Companys accounting policy proportionately upon the receipt of
stated milestones. The agreement with Novartis for the further development of the compound expired
on May 30, 2004 and Novartis has determined to discontinue further development and, accordingly,
the Company recognized the entire amount of deferred revenue of Rs.235,550 (U.S.$5,000) as license
fees during the year ended March 31, 2005.
The Company had entered into a licensing arrangement with Novo Nordisk A/S in February 1997,
whereby the Company had licensed two molecule compounds for further development and conducting
clinical trials. Under the arrangement, the Company received a non-refundable upfront license fee
upon signing of the agreement and was also entitled to receive certain additional non-refundable
payments upon the achievement of certain defined milestones. As of March 31, 2004, the Company had
unamortized non-refundable upfront license fees of Rs.52,832 (U.S.$1,273) on account of the second
molecule compound. On October 22, 2004, Novo Nordisk announced that it had suspended clinical
trials on the second compound also due to unsatisfactory results. Accordingly, the Company has
recognized the entire amount of deferred revenue of Rs.52,832 (U.S.$1,273) as license fees during
the year ended March 31, 2005.
The Company has entered into certain dossier sales, licensing and supply arrangements in
Europe and Japan. These arrangements include certain performance obligations and based on an
evaluation that these obligations are not inconsequential or perfunctory, the Company has deferred
the upfront payments received towards these arrangements. These amounts will be recognized in the
income statement in the period in which the Company completes all its performance obligations.
F-28
DR. REDDYS LABORATORIES LIMITED AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(in thousands, except share data and where otherwise stated)
20. Deferred revenue (continued)
Upon completion of all its performance obligation for some of the contracts, the Company
recognized an amount of Rs.57,355 in the income statement during the year ended March 31, 2005. The
balance amounts aggregating to Rs.58,255 represent the deferred revenue relating to these
arrangements.
21. Employee stock incentive plans
Dr. Reddys Employees Stock Option Plan-2002 (the DRL 2002 Plan):
The Company instituted the DRL 2002 Plan for all eligible employees in pursuance of the
special resolution approved by the shareholders in the Annual General Meeting held on September 24,
2001. The DRL 2002 Plan covers all employees of DRL and all employees and directors of its
subsidiaries. Under the DRL 2002 Plan, the Compensation Committee of the Board (the Compensation
Committee) shall administer the DRL 2002 Plan and grant stock options to eligible employees of the
Company and its subsidiaries. The Compensation Committee shall determine the employees eligible for
receiving the options, the number of options to be granted, the exercise price, the vesting period
and the exercise period. The vesting period is determined for all options issued on the date of the
grant.
The DRL 2002 Plan was amended on July 28, 2004 at the annual general meeting of shareholders
to provide for stock option grants in two categories:
Category A: 1,721,700 stock options out of the total of 2,295,478 reserved for grant
of options having an exercise price equal to the fair market value of the underlying equity shares
on the date of grant; and
Category B: 573,778 stock options out of the total of 2,295,478 reserved for grant of
options having an exercise price equal to the par value of the underlying equity shares (i.e., Rs.5
per option).The fair market value of a share on each grant date falling under Category A above is
defined as the average closing price for 30 days prior to the grant, in the stock exchange where
there is highest trading volume during that period. Notwithstanding the foregoing, the Compensation
Committee may, after getting the approval of the shareholders in the annual general meeting, grant
options with a per share exercise price other than fair market value and par value of the equity
shares.
On January 24, 2005, certain employees surrendered their fair market value options (Category
A) and the Company issued par value options (Category B) to such employees. This transaction was a
modification of the DRL 2002 Plan and the incremental expenses, being the difference between the
fair value of the Category A options on the date of modification and the fair value of the Category
B options as per the guidance in SFAS 123, has been recognized in the statements of operation over
the vesting period of the Category B options.
Stock option activity under the DRL 2002 Plan in the two categories of options (i.e. fair
market value and par value options) was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended March 31, 2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
average |
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
remaining |
|
|
Shares arising |
|
Range of exercise |
|
average |
|
contractual |
|
|
out of options |
|
prices |
|
exercise price |
|
life (months) |
Outstanding at the beginning of the period |
|
|
543,871 |
|
|
Rs. |
884-1,063.02 |
|
|
Rs. |
995.42 |
|
|
|
56 |
|
Granted during the period |
|
|
423,300 |
|
|
|
883-1,396 |
|
|
|
934.44 |
|
|
|
62 |
|
Expired / forfeited during the period |
|
|
(53,132 |
) |
|
|
883-1,063.02 |
|
|
|
962.54 |
|
|
|
|
|
Exercised during the period |
|
|
(3,001 |
) |
|
|
911-1,063.02 |
|
|
|
1,013.12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at the end of the period |
|
|
911,038 |
|
|
|
883-1,396 |
|
|
|
968.95 |
|
|
|
66 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at the end of the period |
|
|
315,068 |
|
|
Rs. |
884-1,063.02 |
|
|
Rs. |
976.15 |
|
|
|
45 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-29
DR. REDDYS LABORATORIES LIMITED AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(in thousands, except share data and where otherwise stated)
21. Employee stock incentive plans (continued)
Category A Fair Market Value Options
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended March 31, 2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
average |
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
remaining |
|
|
Shares arising |
|
Range of exercise |
|
average |
|
contractual |
|
|
out of options |
|
prices |
|
exercise price |
|
life (months) |
Outstanding at the beginning of the period |
|
|
911,038 |
|
|
|
883-1,396 |
|
|
|
968.95 |
|
|
|
66 |
|
Granted during the period |
|
|
466,500 |
|
|
|
747-885 |
|
|
|
872.82 |
|
|
|
82 |
|
Expired / forfeited during the period |
|
|
(352,657 |
) |
|
|
765-1,063.02 |
|
|
|
918.84 |
|
|
|
|
|
Surrendered by employees during the period |
|
|
(725,931 |
) |
|
|
747-1,396 |
|
|
|
928.07 |
|
|
|
|
|
Exercised during the period |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at the end of the period |
|
|
298,950 |
|
|
|
747-1149 |
|
|
|
977.31 |
|
|
|
50 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at the end of the period |
|
|
188,538 |
|
|
Rs. |
883-1,149 |
|
|
Rs. |
996.54 |
|
|
|
35 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Category B Par Value Options
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended March 31, 2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
average |
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
remaining |
|
|
Shares arising |
|
Range of exercise |
|
average |
|
contractual |
|
|
out of options |
|
prices |
|
exercise price |
|
life (months) |
Outstanding at the beginning of the period |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted during the period
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Surrendered |
|
|
280,873 |
|
|
Rs. |
5 |
|
|
Rs. |
5 |
|
|
|
84 |
|
Others |
|
|
102,650 |
|
|
|
5 |
|
|
|
5 |
|
|
|
84 |
|
Forfeited during the period |
|
|
(3,974 |
) |
|
|
5 |
|
|
|
5 |
|
|
|
|
|
Exercised during the period |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at the end of the period |
|
|
379,549 |
|
|
|
5 |
|
|
|
5 |
|
|
|
84 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at the end of the period |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The weighted average grant date fair value for options granted under the DRL 2002 Plan at
fair market value during the years ended March 31, 2004 and March 31, 2005 was Rs.410.50 and
Rs.377.60. The weighted average grant date fair value for options granted under the DRL 2002 Plan
at par value during the year ended March 31, 2005 was Rs.707.40.
Reddy US Therapeutics, Inc. 2000 Equity Ownership Plan:
In fiscal 2001, Reddy US Therapeutics, Inc. (Reddy US), a consolidated subsidiary, adopted
the Reddy US Therapeutics Inc. 2000 Equity Ownership Plan (the US Plan) to provide for issuance
of stock options to its employees and certain related non-employees. When the U.S. Plan was
established, Reddy US reserved 500,000 shares of its common stock for issuance under the plan.
Under the U.S. Plan, stock options were granted at a price per share not less than the fair market
value of the underlying equity shares on the date of grant. The options were to vest over a period
of 4 years from the date of the grant with 25% of the options vesting at the end of each year.
Stock option activity under the U.S. Plan was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended March 31, 2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
average |
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
remaining |
|
|
Shares arising |
|
Range of |
|
average |
|
contractual |
|
|
out of options |
|
exercise prices |
|
exercise price |
|
life (months) |
Outstanding at the beginning of the period |
|
|
293,500 |
|
|
U.S.$ |
0.18 |
|
|
U.S.$ |
0.18 |
|
|
|
71 |
|
Granted during the period |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited during the period |
|
|
(2,000 |
) |
|
|
0.18 |
|
|
|
0.18 |
|
|
|
|
|
Exercised during the period |
|
|
291,500 |
|
|
|
0.18 |
|
|
|
0.18 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at the end of the period |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-30
DR. REDDYS LABORATORIES LIMITED AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(in thousands, except share data and where otherwise stated)
21. Employee stock incentive plans (continued)
The Company during the year ended March 31, 2004, accelerated the vesting period of the
options issued under the RUSTI Plan, 2000. As a result, all of the RUSTI options were vested and
exercised by employees. Contemporaneous with the acceleration, the Company granted a put option to
the employees to swap the RUSTI shares arising out of this acceleration with ADS of the Company at
an agreed ratio of 7 ADS to every 100 outstanding RUSTI shares. All the RUSTI option holders
exercised this put option, which resulted in the Company issuing 20,405 ADS in exchange for all of
the outstanding shares of RUSTI. The transaction was consummated on December 2, 2003 by issuing
the treasury stock acquired during the period. The Company has evaluated this transaction and has
applied the accounting method described in FASB Interpretation No. 44 and EITF Issue No. 00-23,
Issues Related to the Accounting for Stock Compensation under APB Opinion No. 25 and FASB
Interpretation No. 44, and has determined the award as a liability. Consequently an amount of
Rs.25,553 has been accounted as compensation cost. Further, an amount of Rs.155, representing the
unrecognized compensation cost, was recognized as a result of this acceleration.
Accordingly, there were no options outstanding under this plan during the year ended March 31,
2005.
Aurigene Discovery Technologies Ltd. Employee Stock Option Plan (the Aurigene ESOP Plan):
In fiscal 2004, Aurigene Discovery Technologies Limited (Aurigene), a consolidated
subsidiary, adopted the Aurigene ESOP Plan to provide for issuance of stock options to employees.
Aurigene has reserved 4,550,000 of its ordinary shares for issuance under this plan. Under the
Aurigene ESOP Plan, stock options may be granted at a price per share as may be determined by the
Compensation Committee. The options vest at the end of three years from the date of grant of
option.
Stock option activity under the Aurigene ESOP Plan was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended March 31, 2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- average |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
remaining |
|
|
Shares arising out |
|
Range of exercise |
|
Weighted-average |
|
contractual life |
|
|
of options |
|
prices |
|
exercise price |
|
(months) |
Outstanding at the beginning of the period |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted during the period |
|
|
200,000 |
|
|
Rs. |
10 |
|
|
Rs. |
10 |
|
|
|
65 |
|
Expired / forfeited during the period |
|
|
(30,812 |
) |
|
|
10 |
|
|
|
10 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at the end of the period |
|
|
169,188 |
|
|
Rs. |
10 |
|
|
Rs. |
10 |
|
|
|
65 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at the end of the period |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended March 31, 2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- average |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
remaining |
|
|
|
Shares arising out |
|
|
Range of exercise |
|
|
Weighted-average |
|
|
contractual life |
|
|
|
of options |
|
|
prices |
|
|
exercise price |
|
|
(months) |
|
Outstanding at the beginning of the period |
|
|
169,188 |
|
|
Rs. |
10 |
|
|
Rs. |
10 |
|
|
|
65 |
|
Granted during the period |
|
|
342,381 |
|
|
|
10 |
|
|
|
10 |
|
|
|
61 |
|
Expired / forfeited during the period |
|
|
(314,391 |
) |
|
|
10 |
|
|
|
10 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at the end of the period |
|
|
197,178 |
|
|
Rs. |
10 |
|
|
Rs. |
10 |
|
|
|
59 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at the end of the period |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The weighted average grant date fair value for options granted under the Aurigene ESOP
Plan during the years ended March 31, 2004 and March 31, 2005 was Rs.4.82 and Rs.4.29.
F-31
DR. REDDYS LABORATORIES LIMITED AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(in thousands, except share data and where otherwise stated)
21. Employee stock incentive plans (continued)
Aurigene Discovery Technologies Ltd. Management Group Stock Grant Plan (the Management
Plan):
In fiscal 2004, Aurigene adopted the Management Plan to provide for issuance of stock
options to management employees of Aurigene and its subsidiary Aurigene Discovery Technologies Inc.
Aurigene has reserved 2,950,000 ordinary shares for issuance under this plan. Under the
Management Plan, stock options may be granted at a price per share as may be determined by
Aurigenes compensation committee. The options vest on the date of grant of the options.
Stock option activity under the Management Plan was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended March 31, 2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- average |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
remaining |
|
|
Shares arising out |
|
Range of exercise |
|
Weighted-average |
|
contractual life |
|
|
of options |
|
prices |
|
exercise price |
|
(months) |
Outstanding at the beginning of the period |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted during the period |
|
|
783,333 |
|
|
Rs. |
10 |
|
|
Rs. |
10 |
|
|
|
77 |
|
Expired during the period |
|
|
(166,667 |
) |
|
|
10 |
|
|
|
10 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at the end of the period |
|
|
616,666 |
|
|
Rs. |
10 |
|
|
Rs. |
10 |
|
|
|
77 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at the end of the period |
|
|
616,666 |
|
|
Rs. |
10 |
|
|
Rs. |
10 |
|
|
|
77 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended March 31, 2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- average |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
remaining |
|
|
Shares arising out |
|
Range of exercise |
|
Weighted-average |
|
contractual life |
|
|
of options |
|
prices |
|
exercise price |
|
(months) |
Outstanding at the beginning of the period |
|
|
616,666 |
|
|
Rs. |
10 |
|
|
Rs. |
10 |
|
|
|
77 |
|
Granted during the period |
|
|
616,667 |
|
|
|
10 |
|
|
|
10 |
|
|
|
73 |
|
Expired during the period |
|
|
(1,133,333 |
) |
|
|
10 |
|
|
|
10 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at the end of the period |
|
|
100,000 |
|
|
Rs. |
10 |
|
|
Rs. |
10 |
|
|
|
65 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at the end of the period |
|
|
100,000 |
|
|
Rs. |
10 |
|
|
Rs. |
10 |
|
|
|
65 |
|
The weighted average grant date fair value for options granted under the Aurigene
Management Plan during the year ended March 31, 2004 and March 31, 2005 was Rs.4.25 and Rs.3.76.
F-32
DR. REDDYS LABORATORIES LIMITED AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(in thousands, except share data and where otherwise stated)
22. Allowances for sales returns
Product sales are net of allowances for sales returns. The activity in the allowance for sales
returns is given below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended March 31, |
|
|
2003 |
|
2004 |
|
2005 |
Balance at the beginning of the year |
|
Rs. |
84,897 |
|
|
Rs. |
89,026 |
|
|
Rs. |
99,919 |
|
Additional provision |
|
|
193,229 |
|
|
|
169,511 |
|
|
|
105,245 |
|
Sales returns charged to the provision |
|
|
(189,100 |
) |
|
|
(158,618 |
) |
|
|
(110,041 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at the end of the year |
|
Rs. |
89,026 |
|
|
Rs. |
99,919 |
|
|
Rs. |
95,123 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
23. Other (expense)/income, net
Other (expense)/ income consists of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended March 31, |
|
|
2003 |
|
2004 |
|
2005 |
Interest expense, net of capitalized interest |
|
Rs. |
(6,678 |
) |
|
Rs. |
(14,970 |
) |
|
Rs. |
(103,027 |
) |
Interest income |
|
|
342,548 |
|
|
|
421,763 |
|
|
|
374,928 |
|
Gain on sale of available for sale
securities, net |
|
|
6,284 |
|
|
|
24,786 |
|
|
|
64,997 |
|
Loss on sale of subsidiary interest |
|
|
|
|
|
|
(58,473 |
) |
|
|
(8,122 |
) |
Other |
|
|
340,970 |
|
|
|
131,085 |
|
|
|
202,804 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rs. |
683,124 |
|
|
Rs. |
504,191 |
|
|
Rs. |
531,580 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Certain items were presented as Other operating income, net in the annual report to the
stockholders for fiscal 2005. These items have been presented under Other (expense)/income, net
in the consolidated financial statements presented herein. As a result, Other operating income,
net, Total operating expenses, net, Operating income/(loss) and Other (expense)/income, net
as reported and as presented herein has changed as set out below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As reported in annual report to stockholders |
|
As presented herein |
|
|
Year ended March 31, |
|
Year ended March 31, |
|
|
2003 |
|
2004 |
|
2005 |
|
2003 |
|
2004 |
|
2005 |
Other operating income,net |
|
Rs. |
340,970 |
|
|
Rs. |
131,085 |
|
|
Rs. |
202,804 |
|
|
Rs. |
|
|
|
Rs. |
|
|
|
Rs. |
|
|
Total operating expenses,net |
|
|
6,663,628 |
|
|
|
8,523,838 |
|
|
|
10,249,751 |
|
|
|
7,004,598 |
|
|
|
8,654,923 |
|
|
|
10,452,555 |
|
Operating income/(loss) |
|
|
3,558,611 |
|
|
|
2,211,294 |
|
|
|
(163,646 |
) |
|
|
3,217,641 |
|
|
|
2,080,209 |
|
|
|
(366,450 |
) |
Other (expense)/income,net |
|
|
342,154 |
|
|
|
373,106 |
|
|
|
328,776 |
|
|
|
683,124 |
|
|
|
504,191 |
|
|
|
531,580 |
|
24. Shipping costs
Selling, general and administrative expenses include shipping and handling costs of
Rs.428,992, Rs.557,969 and Rs.642,508 for the years ended March 31, 2003, 2004 and 2005
respectively.
25. Income taxes
Income taxes consist of the following:
F-33
DR. REDDYS LABORATORIES LIMITED AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(in thousands, except share data and where otherwise stated)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended March 31, |
|
|
2003 |
|
2004 |
|
2005 |
Pre-tax income |
|
|
|
|
|
|
|
|
|
|
|
|
Domestic |
|
Rs. |
4,233,292 |
|
|
Rs. |
3,021,098 |
|
|
Rs. |
562,343 |
|
Foreign |
|
|
(424,621 |
) |
|
|
(481,060 |
) |
|
|
(455,314 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,808,671 |
|
|
|
2,540,038 |
|
|
Rs. |
107,029 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax benefit / (expense)
attributable to continuing
operations: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current taxes: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Domestic |
|
Rs. |
(402,225 |
) |
|
Rs. |
(202,364 |
) |
|
Rs. |
(249 |
) |
Foreign |
|
|
4,710 |
|
|
|
(1,752 |
) |
|
|
(1,053 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(397,515 |
) |
|
|
(204,116 |
) |
|
|
(1,302 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred taxes: |
|
|
|
|
|
|
|
|
|
|
|
|
Domestic |
|
|
(44,828 |
) |
|
|
20,126 |
|
|
|
190,086 |
|
Foreign |
|
|
44,281 |
|
|
|
114,741 |
|
|
|
(94,507 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(547 |
) |
|
|
134,867 |
|
|
|
95,579 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rs. |
(398,062 |
) |
|
Rs. |
(69,249 |
) |
|
Rs. |
94,277 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred tax benefit / (expense)
attributable to other comprehensive
income. |
|
Rs. |
(7 |
) |
|
Rs. |
(3,873 |
) |
|
Rs. |
5,206 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
25. Income taxes (continued)
The reported income tax expense differed from amounts computed by applying the enacted
tax rates to income / (loss) before income taxes as a result of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended March 31, |
|
|
2003 |
|
2004 |
|
2005 |
Income before income taxes and minority interest. |
|
Rs. |
3,808,671 |
|
|
Rs. |
2,540,038 |
|
|
Rs. |
107,029 |
|
Enacted tax rate in India |
|
|
36.75 |
% |
|
|
35.875 |
% |
|
|
36.5925 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Computed expected tax benefit expense |
|
Rs. |
(1,399,687 |
) |
|
Rs. |
(911,239 |
) |
|
Rs. |
(39,164 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of: |
|
|
|
|
|
|
|
|
|
|
|
|
Differences between Indian and foreign tax rates |
|
|
379 |
|
|
|
(2,325 |
) |
|
|
13,362 |
|
Valuation allowance |
|
|
(136,499 |
) |
|
|
(149,805 |
) |
|
|
(254,243 |
) |
In-process technology written-off |
|
|
|
|
|
|
|
|
|
|
(110,771 |
) |
Expenses not deductible for tax purposes |
|
|
(58,159 |
) |
|
|
(39,149 |
) |
|
|
(36,552 |
) |
ESOP cost not deductible for tax purpose |
|
|
(47,218 |
) |
|
|
(43,831 |
) |
|
|
(52,694 |
) |
Income exempt from income taxes |
|
|
1,054,642 |
|
|
|
856,317 |
|
|
|
333,310 |
|
Foreign exchange (loss) / gains |
|
|
32,433 |
|
|
|
64,008 |
|
|
|
(5,300 |
) |
Incremental deduction allowed for research and
development expenses |
|
|
203,439 |
|
|
|
172,259 |
|
|
|
254,245 |
|
Indexation of capital assets |
|
|
1,091 |
|
|
|
907 |
|
|
|
8,275 |
|
Tax rate change |
|
|
(12,656 |
) |
|
|
12,111 |
|
|
|
(9,466 |
) |
MAT |
|
|
(2,319 |
) |
|
|
(639 |
) |
|
|
(3,910 |
) |
Others |
|
|
(33,508 |
) |
|
|
(27,863 |
) |
|
|
(2,815 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax benefit / (expense) |
|
Rs. |
(398,062 |
) |
|
Rs. |
(69,249 |
) |
|
Rs. |
94,277 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-34
DR. REDDYS LABORATORIES LIMITED AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(in thousands, except share data and where otherwise stated)
25. Income taxes (continued)
The tax effects of significant temporary differences that resulted in deferred tax assets and
liabilities and a description of the items that create these differences is given below:
|
|
|
|
|
|
|
|
|
|
|
As of March 31, |
|
|
2004 |
|
2005 |
Deferred tax assets: |
|
|
|
|
|
|
|
|
Inventory |
|
Rs. |
60,946 |
|
|
Rs. |
62,644 |
|
Deferred revenue |
|
|
112,683 |
|
|
|
5,868 |
|
Accounts payable |
|
|
43,673 |
|
|
|
46,300 |
|
Accounts receivable |
|
|
8,427 |
|
|
|
|
|
Investments |
|
|
90,244 |
|
|
|
93,762 |
|
Operating loss carry-forward |
|
|
409,706 |
|
|
|
874,187 |
|
Capital loss carry forward |
|
|
11,835 |
|
|
|
36,890 |
|
Expenses deferred for tax purposes |
|
|
|
|
|
|
|
|
Research and development expenses |
|
|
51,006 |
|
|
|
52,026 |
|
Employee costs |
|
|
45,138 |
|
|
|
62,009 |
|
Legal costs |
|
|
135,036 |
|
|
|
66,647 |
|
Start-up costs |
|
|
41,482 |
|
|
|
42,138 |
|
Others |
|
|
14,730 |
|
|
|
31,824 |
|
Other current liabilities |
|
|
115,026 |
|
|
|
96,265 |
|
|
|
|
|
|
|
|
|
|
|
|
|
1,139,932 |
|
|
|
1,470,560 |
|
Less: Valuation allowance |
|
|
(525,961 |
) |
|
|
(781,392 |
) |
|
|
|
|
|
|
|
|
|
Deferred tax assets |
|
|
613,971 |
|
|
|
689,168 |
|
|
|
|
|
|
|
|
|
|
Deferred tax liabilities: |
|
|
|
|
|
|
|
|
Property, plant and equipment |
|
|
(716,329 |
) |
|
|
(876,483 |
) |
Intangible assets |
|
|
(214,545 |
) |
|
|
(134,054 |
) |
Investment securities |
|
|
(13,817 |
) |
|
|
(14,094 |
) |
Others |
|
|
(139,787 |
) |
|
|
(45,518 |
) |
|
|
|
|
|
|
|
|
|
Deferred tax liabilities |
|
|
(1,084,478 |
) |
|
|
(1,070,149 |
) |
|
|
|
|
|
|
|
|
|
Net deferred tax assets/(liabilities) |
|
Rs. |
(470,507 |
) |
|
|
(380,981 |
) |
|
|
|
|
|
|
|
|
|
Deferred charges |
|
|
51,169 |
|
|
|
66,123 |
|
|
|
|
|
|
|
|
|
|
In assessing the realizability of deferred tax assets, management considers whether it is
more likely than not that some portion or all of the deferred tax assets will not be realized. The
ultimate realization of the deferred tax assets is dependent upon the generation of future taxable
income during the periods in which the temporary differences become deductible. Management
considers the scheduled reversal of the projected future taxable income and tax planning strategy
in making this assessment. Based on the level of historical taxable income and projections for
future taxable incomes over the periods in which the deferred tax assets are deductible, management
believes that it is more likely than not the Company will realize the benefits of those deductible
differences and tax loss carry forwards, net of the existing valuation allowances. The amount of
the deferred tax assets considered realizable, however, could be reduced in the near term if
estimates of future taxable income are reduced.
Operating loss carry forward comprises business losses and unabsorbed depreciation. The
period for which such losses can be carried forward differs from five years to indefinite.
The company has during the year, set up a full valuation allowance against the deferred tax
asset on account of tax effect of operating losses carry forward and other net deferred tax assets
of AMPNH, RPI, RANV, RPS, RBL, RCSA, DRSA, DRFBL, Reddy US and others amount to Rs.179,816 as the
management based on future profit projections believes that the likelihood of not realizing these
deferred tax assets is more likely than not.
Valuation allowance has been created with regard to operating losses and other net deferred
tax assets arising out of ADTL amounting to Rs.75,615 as this subsidiary specializes in research
activities and the Company believes that the likelihood of not realizing these deferred tax assets
is more likely than not.
Income exempt from tax represents export earnings exempt for tax purposes and earnings derived
from units set up in backward areas for which the Company is eligible for tax concessions under the
local laws.
F-35
DR. REDDYS LABORATORIES LIMITED AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(in thousands, except share data and where otherwise stated)
25. Income taxes (continued)
Incremental deduction allowed for research and development expenses represents tax incentive
provided by the Government of India for carrying out such activities.
As of March 31, 2005 the Company had operating loss carry-forward of Rs.2,457,776 that
expires as follows:
|
|
|
|
|
Expiring in the year ending March 31: |
|
|
|
|
2006 |
|
Rs. |
|
|
2007 |
|
|
21,413 |
|
2008 |
|
|
212,510 |
|
2009 |
|
|
13,844 |
|
2010 |
|
|
|
|
Thereafter (2011 2023) |
|
|
283,331 |
|
Thereafter (indefinite) |
|
|
1,926,678 |
|
|
|
|
|
|
|
|
Rs. |
2,457,776 |
|
|
|
|
|
|
Operating loss carry-forward includes unabsorbed depreciation of Rs.906,531 which can be
carried forward indefinitely.
Further, as of March 31, 2005 the Company had capital loss carry-forward of Rs.176,422 that
expires on March 31, 2013.
Undistributed earnings of the Companys foreign subsidiaries and unrecognized deferred tax
liability on the same amounted to approximately Rs.235,515, Rs.245,906, Rs.273,724 and Rs.86,552,
Rs.88,219, Rs.100,163 as of March 31, 2003, 2004 and 2005 respectively. Such earnings are
considered to be indefinitely reinvested and, accordingly no provision for income taxes has been
recorded on the undistributed earnings.
26. Employee benefit plans
Gratuity benefits: In accordance with applicable Indian laws, the Company provides for gratuity, a
defined benefit retirement plan (the Gratuity Plan) covering certain categories of employees.
The Gratuity Plan provides a lump sum payment to vested employees, at retirement or termination of
employment, an amount based on the respective employees last drawn salary and the years of
employment with the Company. Effective September 1, 1999, the Company established Dr. Reddys
Laboratories Gratuity Fund (the Gratuity Fund). Liabilities with regard to the Gratuity Plan are
determined by an actuarial valuation, based upon which the Company makes contributions to the
Gratuity Fund. Trustees administer the contributions made to the Gratuity Fund. The amounts
contributed to the Gratuity Fund are invested in specific securities as mandated by law and
generally consist of federal and state government bonds and the debt instruments of
government-owned corporations.
In respect of certain other employees of the Company, the gratuity benefit is provided through
annual contribution to a fund managed by the Life Insurance Corporation of India (LIC). Under
this scheme, the settlement obligation remains with the Company, although the LIC administers the
fund and determines the contribution premium required to be paid by the Company.
F-36
DR. REDDYS LABORATORIES LIMITED AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(in thousands, except share data and where otherwise stated)
26. Employee benefit plans (continued)
The following table sets out the funded status of the Gratuity Plan and the amounts recognized
in the Companys financial statements:
|
|
|
|
|
|
|
|
|
|
|
As of March 31, |
|
|
2004 |
|
2005 |
Change in the benefit obligations |
|
|
|
|
|
|
|
|
Projected Benefit Obligations (PBO) at the beginning of the year |
|
Rs. |
113,294 |
|
|
Rs. |
147,309 |
|
Service cost |
|
|
16,061 |
|
|
|
20,379 |
|
Interest cost |
|
|
8,992 |
|
|
|
10,217 |
|
Actuarial (gain)/ loss |
|
|
24,313 |
|
|
|
34,362 |
|
Benefits paid |
|
|
(15,351 |
) |
|
|
(12,228 |
) |
|
|
|
|
|
|
|
|
|
PBO at the end of the year |
|
Rs. |
147,309 |
|
|
Rs. |
200,039 |
|
|
|
|
|
|
|
|
|
|
Change in plan assets |
|
|
|
|
|
|
|
|
Fair value of plan assets at the beginning of the year |
|
Rs. |
91,482 |
|
|
Rs. |
130,939 |
|
Actual return on plan assets |
|
|
42,681 |
|
|
|
(26,003 |
) |
Employer contributions |
|
|
12,127 |
|
|
|
34,414 |
|
Benefits paid |
|
|
(15,351 |
) |
|
|
(12,228 |
) |
|
|
|
|
|
|
|
|
|
Plan assets at the end of the year |
|
Rs. |
130,939 |
|
|
Rs. |
127,122 |
|
|
|
|
|
|
|
|
|
|
Funded status |
|
Rs. |
(16,370 |
) |
|
Rs. |
(72,917 |
) |
Unrecognized actuarial loss |
|
|
21,469 |
|
|
|
92,014 |
|
Unrecognized transitional obligation |
|
|
12,916 |
|
|
|
12,146 |
|
|
|
|
|
|
|
|
|
|
Net amount recognized |
|
Rs. |
18,015 |
|
|
Rs. |
31,243 |
|
|
|
|
|
|
|
|
|
|
Amounts recognized in the statement of financial position consist of:
|
|
|
|
|
|
|
|
|
|
|
Year ended March 31, |
|
|
2004 |
|
2005 |
Prepaid benefit cost |
|
Rs. |
21,591 |
|
|
Rs. |
35,231 |
|
Accrued benefit liability |
|
|
(3,576 |
) |
|
|
(3,988 |
) |
|
|
|
|
|
|
|
|
|
Net amount recognized |
|
Rs. |
18,015 |
|
|
Rs. |
31,243 |
|
|
|
|
|
|
|
|
|
|
The accumulated benefit obligation for the Gratuity Plan was Rs.54,358 and Rs.105,931 as at
March 31, 2004 and 2005 respectively.
Components of Net Periodic Benefit Cost:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended March 31, |
|
|
2003 |
|
2004 |
|
2005 |
Service cost |
|
Rs. |
11,494 |
|
|
Rs. |
16,061 |
|
|
Rs. |
20,379 |
|
Interest cost |
|
|
8,368 |
|
|
|
8,992 |
|
|
|
10,217 |
|
Expected return on plan assets |
|
|
(6,884 |
) |
|
|
(8,831 |
) |
|
|
(10,468 |
) |
Amortization of transition obligation / (assets) |
|
|
770 |
|
|
|
770 |
|
|
|
770 |
|
Recognized net actuarial (gain) / loss |
|
|
637 |
|
|
|
881 |
|
|
|
288 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net amount recognized |
|
Rs. |
14,385 |
|
|
Rs. |
17,873 |
|
|
Rs. |
21,186 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-37
DR. REDDYS LABORATORIES LIMITED AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(in thousands, except share data and where otherwise stated)
26. Employee benefit plans (continued)
Summary of the actuarial assumptions: The actuarial assumptions used in accounting for the Gratuity
Plan are:
Weighted-average assumptions used to determine benefit obligations:
|
|
|
|
|
|
|
|
|
|
|
As at March 31, |
|
|
2004 |
|
2005 |
Discount Rate |
|
|
7.0 |
% |
|
|
8.0 |
% |
Rate of compensation increase |
|
|
7.0 |
% |
|
|
7.0 |
% |
Weighted-average assumptions used to determine net periodic benefit cost:
|
|
|
|
|
|
|
|
|
|
|
Year ended March 31, |
|
|
2004 |
|
2005 |
Discount Rate |
|
|
8.0 |
% |
|
|
8.0 |
% |
Rate of compensation increase |
|
12% for first year |
|
|
|
|
|
|
& 7% thereafter |
|
|
7.0 |
% |
Expected long-term return on plan assets |
|
|
8.0 |
% |
|
|
7.5 |
% |
The expected long-term return on plan assets is based on the expectation of the average long-term
rate of return expected to prevail over the next 15 to 20 years on the types of investments
prescribed as per the statutory pattern of investment.
Plan Assets: The Companys gratuity plan weighted-average asset allocations at March 31, 2004 and
2005, by asset category are as follows:
|
|
|
|
|
|
|
|
|
|
|
Year ended March 31, |
|
|
2004 |
|
2005 |
Debt |
|
|
100 |
% |
|
|
100 |
% |
Cash Flows:
Contributions: The Company expects to contribute Rs.10,078 to its gratuity plan during the year
ended March 31, 2006.
Estimated Future Benefit Payments: The following benefit payments, which reflect expected future
service, as appropriate, are expected to be paid:
|
|
|
|
|
Year ended March 31, |
|
|
|
|
2006 |
|
Rs. |
18,694 |
|
2007 |
|
|
17,449 |
|
2008 |
|
|
22,753 |
|
2009 |
|
|
27,161 |
|
2010 |
|
|
25,492 |
|
2011 to 2015 |
|
Rs. |
157,165 |
|
F-38
DR. REDDYS LABORATORIES LIMITED AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(in thousands, except share data and where otherwise stated)
26. Employee benefit plans (continued)
Superannuation benefits: Apart from being covered under the Gratuity Plan described above, the
senior officers of the Company also participate in a superannuation, a defined contribution plan
administered by the LIC. The Company makes annual contributions based on a specified percentage
of each covered employees salary. The Company has no further obligations under the plan beyond
its annual contributions. The Company contributed Rs.19,395, Rs.24,192 and Rs.26,994 to the
superannuation plan during the years ended March 31, 2003, 2004 and 2005 respectively.
Provident fund benefits: In addition to the above benefits, all employees receive benefits
from a provident fund, a defined contribution plan. Both the employee and employer each make
monthly contributions to the plan each equal to 12% of the covered employees salary. The Company
has no further obligations under the plan beyond its monthly contributions. The Company
contributed Rs.47,455, Rs.58,685 and Rs.64,223 to the provident fund plan during the years ended
March 31, 2003, 2004 and 2005 respectively.
27. Related party transactions
The Company has entered into transactions with the following related parties:
|
|
|
Diana Hotels Limited for availing hotel services; |
|
|
|
|
AR Chlorides for availing processing services of raw materials and intermediates; |
|
|
|
|
Dr. Reddys Holdings Limited for purchase and sale of active pharmaceutical ingredients and intermediates; |
|
|
|
|
Madras Diabetes Research Foundation for undertaking research on behalf of the Company; |
|
|
|
|
Dr. Reddys Heritage Foundation for purchase of services; |
|
|
|
|
SR Enterprises for transportation services; and |
|
|
|
|
Manava Seva Dharma Samvardhani Trust for social contribution to which the Company has made contribution. |
The directors of the Company have either a significant ownership interest, controlling
interest or exercise significant influence over these entities (significant interest entities).
The Company has also entered into transactions with employees, directors of the Company and their
relatives.
One of the Companys executives and U.S. general counsel, hired on July 15, 2002, is a partner
of a law firm that the Company engages for legal services. Legal fees paid by the Company to the
concerned law firm were Rs.373,563, Rs.423,137 and Rs.468,758 during the years ended March 31,
2003, 2004 and 2005 respectively.
The following is a summary of significant related party transactions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended March 31, |
|
|
2003 |
|
2004 |
|
2005 |
Purchases from: |
|
|
|
|
|
|
|
|
|
|
|
|
Significant interest entities |
|
Rs. |
50,943 |
|
|
Rs. |
59,889 |
|
|
Rs. |
45,239 |
|
Reddy Kunshan |
|
|
|
|
|
|
107,801 |
|
|
|
39,278 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales to: |
|
|
|
|
|
|
|
|
|
|
|
|
Significant interest entities |
|
|
763 |
|
|
|
1,185 |
|
|
|
1,055 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Administrative expenses paid to: |
|
|
|
|
|
|
|
|
|
|
|
|
Significant interest entities |
|
|
7,749 |
|
|
|
4,793 |
|
|
|
4,649 |
|
Directors and their relatives |
|
|
16,807 |
|
|
|
16,891 |
|
|
|
17,144 |
|
F-39
DR. REDDYS LABORATORIES LIMITED AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(in thousands, except share data and where otherwise stated)
27. Related party transactions (continued)
The Company has the following amounts due from related parties:
|
|
|
|
|
|
|
|
|
|
|
As of March 31, |
|
|
2004 |
|
2005 |
Directors and their relatives |
|
Rs. |
3,680 |
|
|
Rs. |
3,680 |
|
Employee loans (interest free) |
|
|
39,776 |
|
|
|
18,199 |
|
|
|
|
|
|
|
|
|
|
|
|
Rs. |
43,456 |
|
|
Rs. |
21,879 |
|
|
|
|
|
|
|
|
|
|
The Company has the following amounts due to related parties:
|
|
|
|
|
|
|
|
|
|
|
As of March 31, |
|
|
2004 |
|
2005 |
Significant interest entities |
|
Rs. |
14,009 |
|
|
Rs. |
10,996 |
|
Reddy Kunshan |
|
|
12,410 |
|
|
|
5,401 |
|
Interest free deposit from affiliate |
|
|
53,000 |
|
|
|
|
|
Payable towards legal fees |
|
|
121,751 |
|
|
|
123,106 |
|
|
|
|
|
|
|
|
|
|
|
|
|
201,170 |
|
|
|
139,503 |
|
|
|
|
|
|
|
|
|
|
As of March 31, 2005, the required repayments of employee loans are given below:
|
|
|
|
|
Repayable in the year ending March 31: |
|
|
|
|
2006 |
|
Rs. |
10,812 |
|
2007 |
|
|
5,316 |
|
2008 |
|
|
1,819 |
|
2009 |
|
|
226 |
|
2010 |
|
|
26 |
|
Thereafter |
|
|
|
|
|
|
|
|
|
|
|
Rs. |
18,199 |
|
|
|
|
|
|
28. Commitments and Contingencies
Capital Commitments: As of March 31, 2004 and 2005, the Company had committed to spend
approximately Rs.418,025 and Rs.192,161 respectively, under agreements to purchase property and
equipment. The amount is net of capital advances paid in respect of such purchases.
Guarantees: The Company adopted the provisions of FASB Interpretation No. 45, Guarantors
Accounting and Disclosure Requirements for Guarantees, including Indirect Guarantees of
Indebtedness of Others. The Interpretation requires that the Company recognize the fair value of
guarantee and indemnification arrangements issued or modified by the Company after December 31,
2002, if these arrangements are within the scope of that Interpretation. In addition, under
previously existing generally accepted accounting principles, the Company continues to monitor the
conditions that are subject to the guarantees and indemnifications to identify whether it is
probable that a loss has occurred, and would recognize any such losses under the guarantees and
indemnifications when those losses are estimable.
The Company has entered into a guarantee arrangement, which arose in transactions related to
enhancing the credit standing and borrowings of its affiliate Pathnet.
F-40
Pathnet, an equity investee accounted for by the equity method, secured a financial assistance
of Rs.250 million from ICICI Bank Ltd. (ICICI Bank). To enhance the credit standing of Pathnet,
on December 14, 2001 the Company issued a corporate guarantee
F-41
DR. REDDYS LABORATORIES LIMITED AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(in thousands, except share data and where otherwise stated)
28. Commitments and Contingencies (continued)
amounting to Rs.122.5 million in favor of ICICI Bank. The guarantee will expire in May 2008 and
the liability of the Company may arise in case of non-payment or non-performance of other
obligations of Pathnet under its facilities agreements with ICICI Bank. As of March 31, 2005, our
share of theoutstanding loan amount was Rs.21.0 million.
Litigations / Contingencies: The Company manufactures and distributes Norfloxacin, a formulations
product. Under the Drugs Prices Control Order (the DPCO), the government of India has the
authority to designate a pharmaceutical product as a specified product and fix the maximum
selling price for such product. In 1995, the government of India notified Norfloxacin as a
specified product and fixed the maximum selling price. In 1996, the Company filed a statutory
Form III before the government of India for the upward revision of the price and a legal suit
in the Andhra Pradesh High Court (the High Court) challenging the validity of the notification
on the grounds that the applicable rules of the DPCO were not complied with while fixing the
ceiling price. The High Court had earlier granted an interim order in favor of the Company,
however it subsequently dismissed the case in April 2004. The Company filed a review petition in
the High Court in April 2004 which was also dismissed by the High Court in October 2004. The
Company has appealed to the Supreme court of India by filing a Special Leave Petition. The appeal
is currently pending with the Supreme Court. However, in March 2005, the Company received a notice
from the government of India demanding the recovery of the price charged in excess of the ceiling
price fixed by the government of India including interest thereon. The Company believes that as the
validity of the price notification is under dispute and the litigation is pending before the
Supreme Court, the notice is not a final demand. As of March 31, 2005, the Company has provided an
amount of Rs.183,605 representing the excess of the selling price over the maximum selling price
fixed by the government of India on sales through that date.
Pending resolution of the dispute by the Supreme Court of India, the Company continues to sell
Norfloxacin at prices in excess of the maximum selling price fixed by the government of India. In
the event that the Company is unsuccessful in the litigation in the Supreme Court, it will be
required to remit the sale proceeds in excess of the maximum selling price to the government of
India and penalties or interest if any, the amounts of which are not readily ascertainable.
In October 2004, the Company signed an agreement to sell its equity shares in Reddy Biomed
Russia to KT&T, a Russian company for a total consideration of U.S.$5 million. Under the terms of
the agreement, the transfer of shares is to be completed by September 30, 2005. However, the
Company was subsequently informed that a Moscow court has issued an order of injunction halting the
transfer of shares. The Company is in the process of initiating an appeal against the Moscow court
decision. If the Company is unsuccessful in defending its right to sell the shares, it may not be
in a position to effect the transfer of shares and complete the sale. The Company has fully
provided for its initial investment of U.S $1.93 million in Reddy Biomed Russia in 1997. Pending
resolution of the dispute, the amount received from KT&T has been treated as an advance in the
consolidated financial statements.
During the year ended March 31, 2003, the Central Excise Authorities of India (the
Authorities) issued a demand notice on one of the Companys vendors with regard to the assessable
value of its products supplied to the Company. The Company has been named as a co-defendant in the
notice. The Authorities have demanded payment of Rs.175,718 from the vendor including a penalty of
Rs.90,359. The Authorities, through the same notice, have issued a penalty claim of Rs.70,000
against the company.
Further during the year ended March 31, 2005, the Authorities issued an additional notice on
the vendor demanding Rs.225,999 from the vendor including a penalty of Rs.51,152. The Authorities,
through the same notice, have issued a penalty claim of Rs.6,500 against the Company. The Company
has filed an appeal against these notices with the appellate authorities. Pending resolution of
this appeal, the ultimate liability of the Company is not ascertainable.
The Indian Council for Environmental Legal Action filed a writ in 1989 under article 32 of the
Constitution of India against the Union of India and others in the Supreme Court of India for the
safety of people living in the Patancheru and Bollarum areas of Medak district of Andhra Pradesh.
The Company also has been named in the list of polluting industries.
In 1996, the Andhra Pradesh District Judge proposed that the polluting industries compensate
farmers in the Patancheru, Bollarum and Jeedimetla areas for discharging effluents which damaged
the farmers agricultural land. The compensation was fixed at Rs.1.3 per acre for dry land and
Rs.1.7 per acre for wet land over the following three years. Accordingly, the Company has paid a
total compensation of Rs.2,013. The matter is still pending in the courts and the possibility of
additional liability is remote. The Company would not be able to recover the compensation paid,
even if the decision of the court is in its favor.
F-42
DR. REDDYS LABORATORIES LIMITED AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(in thousands, except share data and where otherwise stated)
28. Commitments and Contingencies (continued)
Additionally, the Company is also involved in other lawsuits, claims, investigations and
proceedings, including patent and commercial matters, which arise in the ordinary course of
business. However, there are no such matters pending that the Company expects to be material in
relation to its business.
F-43
DR. REDDYS LABORATORIES LIMITED AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(in thousands, except share data and where otherwise stated)
29. Segment reporting and related information
a) Segment information
The Chief Operating Decision Maker (CODM) evaluates the Companys performance and allocates
resources based on an analysis of various performance indicators by product segments. The product
segments and the respective performance indicators reviewed by the CODM are as follows:
|
|
|
Formulations Revenues by therapeutic product category; |
|
|
|
|
Active pharmaceutical ingredients and intermediates Gross profit, revenues by geography
and revenues by key products; |
|
|
|
|
Generics Gross profit; |
|
|
|
|
Critical care and biotechnology Gross Profit; and |
|
|
|
|
Drug discovery Revenues and expenses. |
The CODM of the Company does not review the total assets for each reportable segment. The
property and equipment used in the Companys business, depreciation and amortization expenses, are
not fully identifiable with/ allocable to individual reportable segments, as certain assets are
used interchangeably between segments. The other assets are not specifically allocable to the
reportable segments. Consequently, management believes that it is not practicable to provide
segment disclosures relating to total assets since allocation among the various reportable segments
is not possible.
Formulations
Formulations, also referred to as finished dosages, consist of finished pharmaceutical
products ready for consumption by the patient. An analysis of revenues by therapeutic category of
the formulations segment is given below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended March 31, |
|
|
2003 |
|
2004 |
|
2005 |
Gastro Intestinal |
|
Rs. |
1,400,652 |
|
|
Rs. |
1,624,811 |
|
|
Rs. |
1,740,087 |
|
Pain Control |
|
|
1,199,271 |
|
|
|
1,386,362 |
|
|
|
1,540,665 |
|
Cardiovascular |
|
|
1,341,588 |
|
|
|
1,444,055 |
|
|
|
1,494,701 |
|
Anti-Infectives |
|
|
1,020,313 |
|
|
|
1,013,595 |
|
|
|
1,001,797 |
|
Dermatology |
|
|
283,056 |
|
|
|
313,076 |
|
|
|
338,016 |
|
Others |
|
|
1,558,664 |
|
|
|
1,732,039 |
|
|
|
1,526,753 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rs. |
6,803,544 |
|
|
Rs. |
7,513,938 |
|
|
Rs. |
7,642,019 |
|
Intersegment revenues1 |
|
|
88,786 |
|
|
|
19,519 |
|
|
|
17,702 |
|
Adjustments2 |
|
|
(31,963 |
) |
|
|
(25,979 |
) |
|
|
163,192 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
Rs. |
6,860,367 |
|
|
Rs. |
7,507,478 |
|
|
Rs. |
7,822,913 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenues |
|
|
2,373,693 |
|
|
|
2,459,768 |
|
|
|
2,280,473 |
|
Intersegment cost of revenues3 |
|
|
310,586 |
|
|
|
211,182 |
|
|
|
259,727 |
|
Adjustments2 |
|
|
(224,092 |
) |
|
|
(84,424 |
) |
|
|
(47,397 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rs. |
2,460,187 |
|
|
Rs. |
2,586,526 |
|
|
Rs. |
2,492,803 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
4,208,051 |
|
|
|
4,862,507 |
|
|
|
5,119,521 |
|
Adjustments2 |
|
|
192,129 |
|
|
|
58,445 |
|
|
|
210,589 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rs. |
4,400,180 |
|
|
Rs. |
4,920,952 |
|
|
Rs. |
5,330,110 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Intersegment revenues is comprised of transfers to the active pharmaceutical
ingredients and intermediates segment and is accounted for at cost to the transferring
segment. |
|
(2) |
|
The adjustments represent reconciling items to conform the segment information to
U.S. GAAP. Such adjustments primarily relate to elimination of sales made to subsidiaries and
other adjustments. |
|
(3) |
|
Intersegment cost of revenues is comprised of transfers from the active
pharmaceutical ingredients and intermediates segment to formulations and is accounted for at
cost to the transferring segment. |
F-44
DR. REDDYS LABORATORIES LIMITED AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(in thousands, except share data and where otherwise stated)
29. Segment reporting and related information (continued)
Active pharmaceutical ingredients and intermediates
Active pharmaceutical ingredients and intermediates, also known as active pharmaceutical
products or bulk drugs, are the principal ingredients for formulations. Active pharmaceutical
ingredients and intermediates become formulations when the dosage is fixed in a form ready for
human consumption such as a tablet, capsule or liquid using additional inactive ingredients.
An analysis of gross profit for the segment is given below.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended March 31, |
|
|
2003 |
|
2004 |
|
2005 |
Revenues from external customers. |
|
Rs. |
5,562,731 |
|
|
Rs. |
6,973,891 |
|
|
Rs. |
5,946,765 |
|
Intersegment revenues1 |
|
|
590,216 |
|
|
|
602,060 |
|
|
|
742,294 |
|
Adjustments2 |
|
|
187,774 |
|
|
|
52,552 |
|
|
|
255,469 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
Rs. |
6,340,721 |
|
|
Rs. |
7,628,503 |
|
|
Rs. |
6,944,528 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenues |
|
Rs. |
3,597,650 |
|
|
Rs. |
4,666,757 |
|
|
Rs. |
4,499,140 |
|
Intersegment cost of revenues |
|
|
88,786 |
|
|
|
19,519 |
|
|
|
17,702 |
|
Adjustments2 |
|
|
252,226 |
|
|
|
416,082 |
|
|
|
496,713 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rs. |
3,938,662 |
|
|
Rs. |
5,102,358 |
|
|
Rs. |
5,013,555 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
Rs. |
2,466,511 |
|
|
Rs. |
2,889,675 |
|
|
Rs. |
2,172,217 |
|
Adjustments2 |
|
|
(64,452 |
) |
|
|
(363,530 |
) |
|
|
(241,244 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rs. |
2,402,059 |
|
|
Rs. |
2,526,145 |
|
|
Rs. |
1,930,973 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Intersegment revenues is comprised of transfers to formulations, generics and custom
chemical synthesis and are accounted for at cost to the transferring segment. |
|
(2) |
|
The adjustments represent reconciling items to conform the segment information to
U.S. GAAP. Such adjustments primarily relate to elimination of sales made to subsidiaries and
other adjustments. |
An analysis of revenue by geography is given below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended March 31, |
|
|
2003 |
|
2004 |
|
2005 |
North America |
|
Rs. |
2,397,663 |
|
|
Rs. |
1,902,922 |
|
|
Rs. |
1,848,963 |
|
India |
|
|
1,668,773 |
|
|
|
2,160,297 |
|
|
|
1,988,134 |
|
Europe |
|
|
465,965 |
|
|
|
1,626,890 |
|
|
|
1,091,190 |
|
Others |
|
|
1,728,024 |
|
|
|
1,983,551 |
|
|
|
2,032,258 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,260,425 |
|
|
|
7,673,660 |
|
|
|
6,960,545 |
|
Adjustments1 |
|
|
80,296 |
|
|
|
(45,157 |
) |
|
|
(16,017 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rs. |
6,340,721 |
|
|
Rs. |
7,628,503 |
|
|
Rs. |
6,944,528 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
The adjustments represent reconciling items to conform the segment information to
U.S. GAAP. Such adjustments primarily relate to elimination of sales made to subsidiaries and other
adjustments. |
F-45
DR. REDDYS LABORATORIES LIMITED AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(in thousands, except share data and where otherwise stated)
29. Segment reporting and related information (continued)
An analysis of revenues by key products is given below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended March 31, |
|
|
2003 |
|
2004 |
|
2005 |
Ramipril |
|
Rs. |
53,078 |
|
|
Rs. |
1,314,164 |
|
|
Rs. |
783,362 |
|
Ciprofloxacin hydrochloride |
|
|
773,177 |
|
|
|
959,773 |
|
|
|
619,112 |
|
Naproxen sodium |
|
|
400,774 |
|
|
|
437,339 |
|
|
|
470,044 |
|
Ibuprofen |
|
|
455,792 |
|
|
|
394,634 |
|
|
|
460,490 |
|
Ranitidine hydrochloride Form 1 |
|
|
475,557 |
|
|
|
457,449 |
|
|
|
452,025 |
|
Ranitidine HCl Form 2 |
|
|
221,737 |
|
|
|
253,996 |
|
|
|
282,240 |
|
Atorvastatin |
|
|
88,264 |
|
|
|
211,192 |
|
|
|
252,466 |
|
Naproxen |
|
|
160,058 |
|
|
|
233,835 |
|
|
|
229,553 |
|
Nizatidine |
|
|
658,667 |
|
|
|
159,592 |
|
|
|
216,757 |
|
Terbinafine HCl |
|
|
94,027 |
|
|
|
124,923 |
|
|
|
194,482 |
|
Losartan potassium |
|
|
125,471 |
|
|
|
214,231 |
|
|
|
180,528 |
|
Dextromethorphan HBr |
|
|
190,425 |
|
|
|
182,775 |
|
|
|
165,836 |
|
Sertraline hydrochloride |
|
|
143,084 |
|
|
|
178,537 |
|
|
|
138,158 |
|
Sparfloxacin |
|
|
175,816 |
|
|
|
197,055 |
|
|
|
117,520 |
|
Doxazosin mesylate |
|
|
181,448 |
|
|
|
117,878 |
|
|
|
111,644 |
|
Enrofloxacin |
|
|
139,857 |
|
|
|
125,487 |
|
|
|
93,139 |
|
Others |
|
|
2,003,489 |
|
|
|
2,065,643 |
|
|
|
2,177,172 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
Rs. |
6,340,721 |
|
|
Rs. |
7,628,503 |
|
|
Rs. |
6,944,528 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Generics
Generics are generic finished dosages with therapeutic equivalence to branded formulations.
The Company entered the global generics market during the year ended March 31, 2001 with the export
of ranitidine 75mg and oxaprozin to the United States.
An analysis of gross profit for the segment is given below.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended March 31, |
|
|
2003 |
|
2004 |
|
2005 |
Revenues |
|
Rs. |
.4,284,192 |
|
|
Rs. |
4,337,525 |
|
|
Rs. |
3,577,421 |
|
Less: |
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenues |
|
|
809,079 |
|
|
|
989,125 |
|
|
|
1,222,401 |
|
Intersegment cost of revenues1 |
|
|
251,580 |
|
|
|
335,342 |
|
|
|
397,969 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,060,659 |
|
|
|
1,324,467 |
|
|
|
1,620,370 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross Profit |
|
Rs. |
3,223,533 |
|
|
Rs. |
3,013,058 |
|
|
Rs. |
1,957,051 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Intersegment cost of revenues is comprised of transfers from the active
pharmaceutical ingredients and intermediates segment to the generics segment and are accounted for
at cost to the transferring segment. |
F-46
DR. REDDYS LABORATORIES LIMITED AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(in thousands, except share data and where otherwise stated)
29. Segment reporting and related information (continued)
An analysis of revenues by key products for the year ending March 31, 2003, 2004, and 2005 is
given below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended March 31, |
|
|
2003 |
|
2004 |
|
2005 |
Fluoxetine |
|
Rs. |
1,839,104 |
|
|
Rs. |
1,825,546 |
|
|
Rs. |
857,927 |
|
Omeprazole |
|
|
283,011 |
|
|
|
325,304 |
|
|
|
434,090 |
|
Ibuprofen |
|
|
31,568 |
|
|
|
183,973 |
|
|
|
198,666 |
|
Tizanidine |
|
|
777,826 |
|
|
|
591,088 |
|
|
|
206,156 |
|
Amlodipine |
|
|
|
|
|
|
7,797 |
|
|
|
200,459 |
|
Ranitidine |
|
|
225,090 |
|
|
|
205,799 |
|
|
|
194,003 |
|
Others |
|
|
1,127,593 |
|
|
|
1,198,018 |
|
|
|
1,486,120 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rs. |
4,284,192 |
|
|
Rs. |
4,337,525 |
|
|
Rs. |
3,577,421 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Critical care and biotechnology
Diagnostic pharmaceuticals and equipment and specialist products are produced and marketed by
the Company primarily for anti-cancer and critical care. An analysis of net income for the
diagnostics, critical care and biotechnology segment is given below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended March 31, |
|
|
2003 |
|
2004 |
|
2005 |
Revenues |
|
Rs. |
428,179 |
|
|
Rs. |
411,028 |
|
|
Rs. |
527,108 |
|
Cost of revenues |
|
|
234,388 |
|
|
|
206,974 |
|
|
|
176,534 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
Rs. |
193,791 |
|
|
Rs. |
204,054 |
|
|
Rs. |
350,574 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Intersegment cost of revenues is comprised of transfers from the active
pharmaceutical ingredients and intermediates segment to the critical care and biotechnology segment
and are accounted for at cost to the transferring segment. |
Drug discovery
The Company is involved in drug discovery through the research facilities located in the
United States and India. The Company commercializes drugs discovered with other products and also
licenses these discoveries to other companies. An analysis of the revenues and expenses of the
drug discovery segment is given below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended March 31, |
|
|
2003 |
|
2004 |
|
2005 |
Revenues |
|
Rs. |
|
|
|
Rs. |
|
|
|
Rs. |
288,382 |
|
Adjustments1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rs. |
288,382 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
expenses |
|
Rs. |
480,111 |
|
|
Rs. |
729,434 |
|
|
Rs. |
868,992 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
The adjustments represent reconciling items to conform the segment
information with U.S. GAAP. Such adjustments primarily relate to deferral of up-front
non-refundable license fees. |
F-47
DR. REDDYS LABORATORIES LIMITED AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(in thousands, except share data and where otherwise stated)
29. Segment reporting and related information (continued)
a) Reconciliation of segment information to entity total
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended March 31, 2003 |
|
Year ended March 31, 2004 |
|
Year ended March 31, 2005 |
|
|
Revenues |
|
Gross profit |
|
Revenues |
|
Gross profit |
|
Revenues |
|
Gross profit |
Formulations |
|
Rs. |
6,860,367 |
|
|
Rs. |
4,400,180 |
|
|
Rs. |
7,507,478 |
|
|
Rs. |
4,920,952 |
|
|
Rs. |
7,822,913 |
|
|
Rs. |
5,330,110 |
|
Active
pharmaceutical
ingredients and
intermediates |
|
|
6,340,721 |
|
|
|
2,402,059 |
|
|
|
7,628,503 |
|
|
|
2,526,145 |
|
|
|
6,944,528 |
|
|
|
1,930,973 |
|
Generics |
|
|
4,284,192 |
|
|
|
3,223,533 |
|
|
|
4,337,525 |
|
|
|
3,013,058 |
|
|
|
3,577,421 |
|
|
|
1,957,051 |
|
Critical care and
biotechnology |
|
|
428,179 |
|
|
|
193,791 |
|
|
|
411,028 |
|
|
|
204,054 |
|
|
|
527,108 |
|
|
|
350,574 |
|
Drug discovery |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
288,382 |
|
|
|
288,382 |
|
Others |
|
|
156,353 |
|
|
|
2,676 |
|
|
|
196,715 |
|
|
|
70,923 |
|
|
|
311,573 |
|
|
|
229,015 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rs. |
18,069,812 |
|
|
Rs. |
10,222,239 |
|
|
Rs. |
20,081,249 |
|
|
Rs. |
10,735,132 |
|
|
Rs. |
19,471,925 |
|
|
Rs. |
10,086,105 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
b) Analysis of revenue by geography
The Companys business is organized into five key geographic segments. Revenues are
attributable to individual geographic segments based on the location of the customer.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended March 31, |
|
|
|
2003 |
|
2004 |
|
2005 |
India |
|
Rs. |
6,488,573 |
|
|
Rs. |
7,143,798 |
|
|
Rs. |
6,693,042 |
|
North America |
|
|
5,852,552 |
|
|
|
5,319,160 |
|
|
|
4,349,191 |
|
Russia and other countries of the former Soviet Union |
|
|
2,107,861 |
|
|
|
2,285,838 |
|
|
|
2,782,171 |
|
Europe |
|
|
1,401,008 |
|
|
|
2,788,648 |
|
|
|
2,868,233 |
|
Others |
|
|
2,219,818 |
|
|
|
2,543,805 |
|
|
|
2,779,288 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rs. |
18,069,812 |
|
|
Rs. |
20,081,249 |
|
|
Rs. |
19,471,925 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
c) Analysis of property, plant and equipment by geography
Property, plant and equipment (net) attributed to individual geographic segments are given
below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of March 31, |
|
|
2003 |
|
2004 |
|
2005 |
India |
|
Rs. |
4,577,973 |
|
|
Rs. |
5,998,005 |
|
|
Rs. |
6,723,966 |
|
North America |
|
|
106,093 |
|
|
|
156,981 |
|
|
|
157,549 |
|
Russia and other countries of the former Soviet Union |
|
|
31,103 |
|
|
|
36,606 |
|
|
|
34,681 |
|
Europe |
|
|
111,740 |
|
|
|
132,721 |
|
|
|
122,449 |
|
Others |
|
|
3,571 |
|
|
|
6,822 |
|
|
|
19,663 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rs. |
4,830,480 |
|
|
Rs. |
6,331,135 |
|
|
Rs. |
7,058,308 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-48
Item 19. Exhibits
|
|
|
|
|
|
|
|
|
Exhibit Number |
|
Description of Exhibits |
|
|
|
1.1.*/*** |
|
|
Memorandum and Articles of Association of the
Registrant dated February 4, 1984. |
|
|
|
|
|
|
|
|
|
|
1.2.*/*** |
|
|
Certificate of Incorporation of the Registrant dated
February 24, 1984. |
|
|
|
|
|
|
|
|
|
|
1.3.*/*** |
|
|
Amended Certificate of Incorporation of the
Registrant dated December 6, 1985. |
|
|
|
|
|
|
|
|
|
|
2.1.* |
|
|
Form of Deposit Agreement, including the form of
American Depositary Receipt, among Registrant, Morgan
Guaranty Trust Company as Depositary, and holders
from time to time of American Depositary Receipts
Issued there under, including the form of American
Depositary. |
|
|
|
|
|
|
|
|
|
|
4.1.* |
|
|
Agreement by and between Dr. Reddys Laboratories
Limited and Dr. Reddys Research Foundation regarding
the undertaking of research dated February 27, 1997. |
|
|
|
|
|
|
|
|
|
|
4.2.** |
|
|
Dr. Reddys Laboratories Limited Employee Stock Option
Scheme, 2002. |
|
|
|
|
|
|
|
|
|
|
8. |
|
|
List of subsidiaries of the Registrant. |
|
|
|
|
|
|
|
|
|
|
23.1 |
|
|
Consent of Independent Registered Public Accounting Firm |
|
|
|
|
|
|
|
|
|
|
99.1 |
|
|
Certification of Chief Executive Officer, pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002. |
|
|
|
|
|
|
|
|
|
|
99.2 |
|
|
Certification of Chief Financial Officer, pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002. |
|
|
|
|
|
|
|
|
|
|
99.3 |
|
|
Certification of Chief Executive Officer, pursuant to
18 U.S.C. Section 1350, as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002. |
|
|
|
|
|
|
|
|
|
|
99.4 |
|
|
Certification of Chief Financial Officer, pursuant to
18 U.S.C. Section 1350, as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002. |
|
|
|
* |
|
Previously filed on March 26, 2001 with the SEC along with Form F-1 |
|
** |
|
Previously filed with the Companys Form 20-F for the year ended March 31, 2002 |
|
*** |
|
Previously filed with the Companys Form 20-F for the year ended March 31, 2003 |
SIGNATURES
The registrant hereby certifies that it meets all of the requirements for filing on Form 20F and
that it has duly caused and authorized the undersigned to sign this Annual Report on its behalf
|
|
|
|
|
|
|
For Dr. Reddys Laboratories Limited, |
|
|
|
|
|
|
|
By:
|
|
/s/ G.V. Prasad |
|
|
|
|
|
|
|
|
|
G.V. Prasad |
|
|
|
|
Executive Vice Chairman & CEO |
|
|
|
|
|
|
|
For Dr. Reddys Laboratories Limited, |
|
|
|
|
|
|
|
By:
|
|
/s/ V. S. Vasudevan |
|
|
|
|
|
|
|
|
|
V. S. Vasudevan |
Hyderabad, India
|
|
|
|
Chief Financial Officer |
August 8, 2005 |
|
|
|
|