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DR REDDYS LABORATORIES LTD Regulatory Filings 2012

Nov 6, 2012

30528_ffr_2012-11-06_ff01bb14-a05a-4cf7-b4e1-9d9f3da07113.zip

Regulatory Filings

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FORM 6-K

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Report of Foreign Private Issuer

Pursuant to Rule 13a-16 or 15d-16 of

the Securities Exchange Act of 1934

Month of October 2012

Commission File Number – 1-15182

DR. REDDY’S LABORATORIES LIMITED

(Name of Registrant)

8-2-337, Road No. 3, Banjara Hills

Hyderabad, Andhra Pradesh 500 034, India

+91-40-4900-2900

(Address of Principal Executive Offices)

Indicate by check mark whether registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F x Form 40-F ¨

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ¨

Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ¨

Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrant’s “home country”), or under the rules of the home country exchange on which the registrant’s securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrant’s security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.

Indicate by check mark whether by furnishing the information contained in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.

Yes ¨ No x

If “Yes” is marked, indicate below the file number assigned to registrant in connection with Rule 12g3-2(b):

Not applicable.

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| (1) | Press Release, “Dr. Reddy’s Custom Pharmaceutical Services (CPS) business expands its manufacturing operations in Mirfield, UK,” October
8, 2012. |
| --- | --- |
| (2) | Press Release, “Dr. Reddy’s Q2 & H1 FY13 Financial Results”, October 30, 2012. |

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Press Release
Dr. Reddy’s Laboratories Ltd.
8-2-337, Road No. 3
Banjara Hills, Hyderabad - 500 034
Andhra Pradesh, India
Tel: 91-40-4900-2900
Fax: 91-40-4900-2999
www.drreddys.com

Dr. Reddy’s Custom Pharmaceutical Services (CPS) business expands its manufacturing operations in Mirfield, UK.

Hyderabad, India, October 08, 2012 The Custom Pharmaceutical Services (CPS) business of Dr. Reddy’s Laboratories Ltd. (NYSE: RDY) today announced expansion in the areas of activated mPEG manufacturing and in the development and manufacture of NCE (New Chemical Entities) APIs for use in pre-clinical through to commercial development at its manufacturing facility in Mirfield, UK.

The expansion puts Dr. Reddy’s at the forefront of activated mPEG manufacturing and will enable manufacture of its PEGtech TM range at commercial metric tonne scale quantities and beyond in a fully cGMP environment. Equipped with state-of-the-art DCS computer control systems, the plant operates with a very high level of control and has been designed with the latest manufacturing compliance standards in mind.

Commenting on the development, Dr. R. Ananthanarayanan, President-Pharmaceutical Services and Active Ingredients business, Dr. Reddy’s said, “This expansion builds on our commitment to expand operations in UK and provide a superior network of cGMP manufacturing to support our global customer base. PEGylation is one area where we felt the need for expanding our capabilities. We have invested in multiple technology areas and the expansion will add significant value in the areas of mPEGs and cGMP API manufacturing”.

Dr. Reddy’s has eight API manufacturing facilities (Six FDA-approved plants in India, One FDA-approved plant in Mexico and One FDA-approved plant in Mirfield, UK) worldwide which helps the CPS business to provide its customers with multiple site options.

Disclaimer

This press release includes forward-looking statements, as defined in the U.S. Private Securities Litigation Reform Act of 1995. We have based these forward-looking statements on our current expectations and projections about future events. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results to differ materially. Such factors include, but are not limited to, changes in local and global economic conditions, our ability to successfully implement our strategy, the market acceptance of and demand for our products, our growth and expansion, technological change and our exposure to market risks. By their nature, these expectations and projections are only estimates and could be materially different from actual results in the future.

About Dr. Reddy’s

Dr. Reddy’s Laboratories Ltd. (NYSE: RDY) is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses—Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars, differentiated formulations and NCEs. Therapeutic focus is on gastro-intestinal, cardiovascular, diabetology, oncology, pain management, anti-infective and pediatrics. Major markets include India, USA, Russia and CIS, Germany, UK, Venezuela, S. Africa, Romania, and New Zealand. For more information, log on to: www.drreddys.com

For more information, please contact:

Investors and Financial Analysts: Business Development:
Kedar Upadhye at [email protected] /+91-40-66834297 Mark Pearson at [email protected]
Saunak Savla at [email protected] /+91-40-49002135 Christian Jones at [email protected]
Milan Kalawadia (USA) at [email protected] /+1 908-203-4931
Media:
S Rajan at [email protected] / +91-40-49002445

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Press Release
Dr. Reddy’s Laboratories Ltd.
8-2-337, Road No. 3
Banjara Hills, Hyderabad - 500 034
Andhra Pradesh, India
Tel: 91-40-4900-2900
Fax: 91-40-4900-2999
www.drreddys.com

Dr. Reddy’s Q2 & H1 FY13 Financial Results

Q2 FY13 Revenues at 28.8 billion (YoY growth of 27%) Q2 FY13 EBITDA at 7.7 billion (YoY growth of 47%) Adjusted Q2 FY13 PAT at 4.9 billion (YoY growth of 77%) H1 FY13 Revenues at 54.2 billion (YoY growth of 28%) H1 FY13 EBITDA at 12.7 billion (YoY growth of 35%) *Adjusted H1 FY13 PAT at 7.8 billion (YoY growth of 56%)

In this Quarterly Report, references to “$” or “dollars” or “U.S.$” or “U.S. dollars” are to the legal currency of the United States and references to “ ” or “rupees

Hyderabad, India, October 30, 2012: Dr. Reddy’s Laboratories Ltd. (NYSE: RDY) today announced its unaudited consolidated financial results for the quarter ended September 30, 2012 under International Financial Reporting Standards (IFRS).

Key Highlights (Q2 FY13)

• Consolidated revenues for Q2 FY13 at 28.8 billion, recorded YoY growth of 27%. Consolidated revenues for H1 FY13 at 54.2 billion, recorded YoY growth of 28%.

• Revenues from the Global Generics segment for Q2 FY13 at 20.1 billion, recorded YoY growth of 25% primarily driven by North America, India and other emerging markets.

• Revenues from the PSAI segment for Q2 FY13 at 7.9 billion, recorded YoY growth of 33%.

• EBITDA for Q2 FY13 at 7.7 billion, 27% of revenues, recorded YoY growth of 47%. EBITDA for H1 FY13 at 12.7 billion, 23% of revenues, recorded YoY growth of 35%.

• PAT for Q2 FY13 at 4.1 billion, 14% of revenues, recorded YoY growth of 32%. PAT for H1 FY13 at 7.4 billion, 14% of revenues, recorded YoY growth of 30%.

• *Adjusted PAT for Q2 FY13 at 4.9 billion, 17% of revenues, recorded YoY growth of 77%.

• During the quarter, the company launched 18 new generic products, filed 11 new product registrations and filed 10 DMFs globally.

  • Adjusted for (a) impairment charges in Q2 FY13 (b) the benefit on reversal of provision for voluntary retirement scheme (‘VRS’)in Q2 FY 12 and (c) tax normalization on account of the annual effective tax rate and the aforementioned adjustments

** Adjusted for (a) impairment charges in Q2 FY13 (b) net charge for voluntary retirement scheme(‘VRS’) and (c) tax normalization on account of the annual effective tax rate and the aforementioned adjustments

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All figures in millions, except EPS All US dollar figures based on convenience translation rate of 1USD = 52.92

Dr. Reddy’s Laboratories Limited and Subsidiaries

Unaudited Consolidated Income Statement

Particulars — ($) ( ) % ($) ( ) % %
Revenues 544 28,809 100 429 22,678 100 27
Cost of revenues 255 13,504 47 198 10,473 46 29
Gross profit 289 15,305 53 231 12,205 54 25
Operating Expenses
Selling, general and administrative expenses 151 8,013 28 136 7,217 32 11
Research and development expenses 33 1,759 6 28 1,459 6 21
Impairment loss on goodwill and intangible assets 13 688 2
Other operating (income) / expense (8 ) (397 ) (1 ) (4 ) (216 ) (1 ) 85
Results from operating activities 99 5,242 18 71 3,745 17 40
Net finance (income) / expense (7 ) (371 ) (1 ) 1 50 0 (849 )
Share of (profit) / loss of equity accounted investees (1 ) (28 ) (0 ) (0 ) (13 ) (0 ) 115
Profit before income tax (‘PBT’) 107 5,641 20 70 3,708 16 52
Income tax expense 30 1,567 5 12 630 3 148
Profit for the period 77 4,074 14 58 3,078 14 32
Diluted EPS 0.5 23.9 0.3 18.1 32

Profit Computation:

EBITDA Computation Q2 FY13 — ($) ( ) ($) ( )
PBT 107 5,641 70 3,708
Net Interest Expenses / (Income) (1 ) (32 ) 4 225
Depreciation 18 943 17 879
Amortization 8 433 7 389
Impairment 13 688
Reported EBITDA 145 7,673 98 5,201
Adjustments of exceptional items:
Part reversal of provision booked in Q1 FY12 for VRS (2 ) (94 )
Adjusted EBITDA 145 7,673 97 5,107
PAT Computation Q2 FY13 Q2 FY12
($) ( ) ($) ( )
PAT 77 4,074 58 3,078
Adjustments:
Part reversal of provision booked in Q1 FY12 for VRS (2 ) (94 )
Impairment loss on goodwill and intangible assets 13 688
Tax adjustment* 3 175 (4 ) (192 )
Adjusted PAT 93 4,937 53 2,792
  • Q2 FY13 normalized to the FY13 annual effective tax rate and Q2 FY12 normalized to the FY12 annual effective tax rate and the effect of the aforementioned adjustments

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SEGMENTAL ANALYSIS

Global Generics

Revenues from Global Generics segment for Q2 FY13 at 20.1 billion, recorded YoY growth of 25% driven by key markets of North America, India and other emerging markets.

• Revenues from North America for Q2 FY13 at 9.3 billion, recorded YoY growth of 47%.

• Growth is largely driven by key limited competition products of ziprasidone, tacrolimus, fondaparinux, clopidogrel, ramp-up in antibiotics portfolio and products from Shreveport facility.

• 4 new products were launched during the quarter—atorvastatin, metoprolol, montelukast family and amoxicillin.

• 30 products from the prescription portfolio are ranked among the Top 3 in their respective market shares. (Source: IMS Health Volumes, August 2012)

• During the quarter, 4 ANDAs were filed. Cumulatively, 63 ANDAs are pending for approval with the USFDA of which 33 are Para IVs and 7 have ‘First To File’ status.

• Revenues from Russia and Other CIS markets for Q2 FY13 at 3.8 billion recorded YoY growth of 14%.

• Revenues from Russia for Q2 FY13 are at 3.2 billion.

• Revenues from Other CIS markets for Q2 FY13 at 0.62 billion recorded YoY growth of 31%.

• Revenues from India for Q2 FY13 at 3.9 billion recorded YoY growth of 12%.

• Growth driven by volume increase across most key brands.

• Biosimilars portfolio grew YoY by 24% during the quarter.

• 4 new brands were launched during the quarter.

• Revenues from Europe for Q2 FY13 at 1.8 billion declined YoY by 16%.

• Revenues from Germany for Q2 FY13 at 1.1 billion declined YoY by 11%.

Pharmaceutical Services and Active Ingredients (PSAI)

• Revenues from PSAI for Q2 FY13 at 7.9 billion, recorded YoY growth of 33%.

• During the quarter, 10 DMFs were filed globally, including 2 in Europe. The cumulative number of DMF filings as of September 30, 2012 is 552.

Income Statement Highlights:

• Gross profit margin at 53.1% in Q2 FY13 marginally dropped by 0.7% versus Q2 FY12. Gross profit margin for Global Generics and PSAI business segments are at 59.4% and 35.8% respectively.

• Selling, General and Administration (SG&A) expenses including amortization at 8 billion increased YoY by 11%.

• Research & development expenses for Q2 FY13 at 1.8 billion is at 6% of revenues.

• During the quarter, a non-recurring and non-cash impairment charge of 688 million pertaining to product intangibles in generics portfolio and a goodwill charge wrt Italian operations has been considered.

• Net Finance income is at 371 million, in Q2 FY13 compared to the net finance cost of 50 million in Q2 FY12. The change is on account of :

• Net incremental forex gain of 187 million, primarily on account of reversal of the loss on time value of options recorded in Q1 FY13, due to the recent appreciation in the rupee.

• Net interest income of 33 million in Q2 FY13 compared to net interest expense of 225 million in Q2 FY12 primarily on account of higher interest income from Fixed Deposit and mutual funds.

• EBITDA for Q2 FY13 is 7.7 billion, 27% of revenues and recorded YoY growth of 47%. This growth is supported by the increased operating leverage.

• Profit after Tax in Q2 FY13 at 4.1 billion recorded YoY growth of 32%.

• *Adjusted Profit after tax in Q2 FY13 at 4.9 billion recorded YoY growth of 77%.

• Diluted earnings per share in Q2 FY 13 are 23.9.

• Capital expenditure for Q2 FY13 is 1.8 billion.

  • Adjusted for (a) impairment charges in Q2 FY13 (b) the benefit on reversal of provision for voluntary retirement scheme (‘VRS’)in Q2 FY 12 and (c) tax normalization on account of the annual effective tax rate and the aforementioned adjustments

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All US dollar figures based on convenience translation rate of 1USD = 52.92

Appendix 1: Key Balance Sheet Items

Particulars (in millions) — As on 30th Sep 12 As on 30th Jun 12
($) ( ) ($) ( )
Cash and cash equivalents 390 20,641 403 21,353
Trade receivables 496 26,247 472 24,975
Inventories 414 21,885 389 20,580
Property, plant and equipment 667 35,300 653 34,550
Goodwill and Other Intangible assets 233 12,297 257 13,597
Loans and borrowings (current & non current) 660 34,901 670 35,430
Trade payables 197 10,412 165 8,750
Equity 1,197 63,354 1,127 59,664

Appendix 2: Revenue Mix by Segment

Q2 FY13 Q2 FY12 Growth %
($) ( ) % ($) ( ) %
Global Generics 380 20,103 70 305 16,136 71 25
North America 9,270 46 6,287 39 47
Europe 1,777 9 2,117 13 (16 )
India 3,879 19 3,459 21 12
Russia & Other CIS 3,841 19 3,380 21 14
RoW 1,336 7 893 6 50
PSAI 149 7,876 27 112 5,933 26 33
North America 1,353 17 1,068 18 27
Europe 2,906 37 2,303 39 26
India 1,148 15 752 13 53
RoW 2,469 31 1,810 31 36
Proprietary Products & Others 16 830 3 12 610 3 36
Total 544 28,809 100 429 22,678 100 27

Appendix 3: Consolidated Income Statement

Particulars
($) ( ) % ($) ( ) %
Revenues 1,024 54,215 100 802 42,461 100 28
Cost of revenues 479 25,369 47 372 19,701 46 29
Gross profit 545 28,846 53 430 22,760 54 27
Operating Expenses
Selling, general and administrative expenses 308 16,291 30 264 13,972 33 17
Research and development expenses 63 3,322 6 50 2,656 6 25
Impairment loss on goodwill and intangible assets 13 688 1
Other operating (income) / expense (12 ) (615 ) (1 ) (8 ) (402 ) (1 ) 54
Results from operating activities 173 9,160 17 123 6,534 15 40
Net finance (income) / expense (3 ) (159 ) (0 ) 2 96 0 (266 )
Share of (profit) / loss of equity accounted investees (1 ) (47 ) (0 ) (0 ) (17 ) (0 ) 176
Profit before income tax 177 9,366 17 122 6,455 15 45
Income tax expense 37 1,932 4 14 750 2 157
Profit for the period 140 7,434 14 108 5,705 13 30
Diluted EPS 0.8 43.6 0.6 33.5 30

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All figures in millions, except EPS All US dollar figures based on convenience translation rate of 1USD = 52.92

Appendix 4: Profit Computation:

EBITDA Computation — ($) ( ) ($) ( )
PBT 177 9,366 122 6,455
Net Interest Expenses / (Income) 0 12 8 446
Depreciation 35 1,839 32 1,708
Amortization 16 833 15 794
Impairment 13 688
Reported EBITDA 241 12,738 178 9,403
Adjustments of exceptional items:
One-time charge of Voluntary Retirement Scheme 1 42
Adjusted EBITDA 241 12,738 178 9,445
PAT Computation — ($) ( ) ($) ( )
PAT 140 7,434 108 5,705
Adjustments:
One-time charge of Voluntary Retirement Scheme 1 42
Impairment loss on goodwill and intangible assets 13 688
Tax adjustment* (5 ) (280 ) (14 ) (729 )
Adjusted PAT 148 7,842 95 5,018
  • H1 FY13 normalized to the FY13 annual effective tax rate and H1 FY12 normalized to the FY12 annual effective tax rate and the effect of the aforementioned transactions

About Dr. Reddy’s

Dr. Reddy’s Laboratories Ltd. (NYSE: RDY) is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars, differentiated formulations and NCEs. Therapeutic focus is on gastro¬intestinal, cardiovascular, diabetology, oncology, pain management, anti¬infective and pediatrics. Major markets include India, USA, Russia and CIS, Germany, UK, Venezuela, S. Africa, Romania and New Zealand. For more information, log on to: www.drreddys.com

Disclaimer

This press release includes forward-looking statements, as defined in the U.S. Private Securities Litigation Reform Act of 1995. We have based these forward-looking statements on our current expectations and projections about future events. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results to differ materially. Such factors include, but are not limited to, changes in local and global economic conditions, our ability to successfully implement our strategy, the market acceptance of and demand for our products, our growth and expansion, technological change and our exposure to market risks. By their nature, these expectations and projections are only estimates and could be materially different from actual results in the future.

CONTACT INFORMATION

Investors and Financial Analysts: Media:
Kedar Upadhye at [email protected] /+91-40-66834297 S Rajan at [email protected] / +91-40-49002445
Saunak Savla at [email protected] /+91-40-49002135
Milan Kalawadia (USA) at [email protected] /+1 908-203-4931

Note: All discussions in this release are based on unaudited consolidated IFRS financials.

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Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

DR. REDDY’S LABORATORIES LIMITED
(Registrant)
Date: November 6, 2012 By: /s/ Sandeep Poddar
Name: Sandeep Poddar
Title: Company Secretary

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