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DR REDDYS LABORATORIES LTD Regulatory Filings 2011

Oct 26, 2011

30528_ffr_2011-10-26_01eef0e8-9277-4645-ac97-b0b90fd9dd4f.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 2011

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 þ Form 40-F o

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

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

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

Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the 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 o No þ

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

Not applicable.

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(1) Press Release, “Dr. Reddy’s Q2 FY12 Financial Results,” October 25, 2011. 3
(2) Press Release, “Teva and Dr. Reddy’s announce launch of generic Zyprexa ® in the United States,” October 25, 2011. 9

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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 FY12 Financial Results

Q2 FY12 Revenues at 22.7 billion ($462 million), YoY growth of 21%

Q2 FY12 Adjusted EBITDA at 5.1 billion ($104 million),** YoY growth of 20%***

Q2 FY12 Adjusted PAT at 3.1 billion ($63 million), YoY growth of 8%**

Hyderabad, India, October 25, 2011: Dr. Reddy’s Laboratories Ltd. (NYSE: RDY) today announced its unaudited consolidated financial results for the quarter ended September 30, 2011 under International Financial Reporting Standards (IFRS).

Key Highlights

• Consolidated revenues are at 22.7 billion ($462 million) in Q2 FY12 versus 18.7 billion ($381 million) in Q2 FY11, year-on-year growth of 21%. Consolidated revenues for H1 FY12 is at 42.5 billion ($866 million).

• Revenues from Global Generics for Q2 FY12 are at 16.1 billion ($329 million). Year-on-year growth of 18% mainly driven by North America and Russia.

• Revenues from PSAI are at 5.9 billion ($121 million) in Q2 FY12, growth of 28% over previous year.

• Adjusted* EBITDA of 5.1 billion ($104 million) in Q2 FY12, is at 23% of revenues recording year-on-year growth of 20%. Consolidated adjusted EBITDA for H1 FY12 is at 9.4 billion ($193 million).

• Adjusted**Profit after Tax for Q2 FY12 is at 3.1 billion ($63 million), is at 14% of revenues with year-on-year growth of 8%. Consolidated adjusted PAT for H1 FY12 is at 5.6 billion ($115 million).

• During the quarter, the company launched 28 new generic products, filed 17 new product registrations and filed 11 DMFs globally.

• Dr. Reddy’s today announced the final approval of its olanzapine 20 mg tablets, the generic version of Eli Lilly’s Zyprexa ® from the USFDA.

| * | Note: Adjustments include: benefit from a part reversal of provision booked in Q1 for Voluntary
Retirement Scheme (VRS) floated by the company. |
| --- | --- |
| ** | Note: Adjustments include: a) interest on bonus debentures and b) benefit from a part reversal
of provision booked in Q1 on account of Voluntary Retirement Scheme (VRS) floated by the
company. |

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All figures in millions, except EPS All US dollar figures based on convenience translation rate of 1USD = 49.05

Dr. Reddy’s Laboratories Limited and Subsidiaries Unaudited Consolidated Income Statement

Particulars Q2 FY12 — ($) ( ) % ($) ( ) % %
Revenue 462 22,679 100 381 18,704 100 21
Cost of revenues 214 10,473 46 178 8,718 47 20
Gross profit 249 12,206 54 204 9,986 53 22
Operating Expenses
Selling, general & administrative expenses 147 7,216 32 116 5,709 31 26
Research and development expenses 30 1,459 6 26 1,270 7 15
Other operating (income) / expense (4 ) (215 ) (1 ) (4 ) (218 ) (1 ) (2 )
Results from operating activities 76 3,745 17 66 3,225 17 16
Net finance (income) / expense 1 50 0 1 35 0 42
Share of (profit) / loss of equity accounted investees (0 ) (13 ) (0 ) (0 ) (3 ) (0 ) —
Profit / (loss) before income tax 76 3,709 16 65 3,194 17 16
Income tax (benefit) / expense 13 631 3 7 327 2 93
Profit / (loss) for the period 63 3,078 14 58 2,867 15 7
Diluted EPS 0.4 18.1 0.3 16.9

Profit Reconciliation:

Adjusted EBITDA Reconciliation Q2 FY12 — ($) ( ) ($) ( )
PBT 76 3,709 65 3,194
Interest 5 225 0 6
Depreciation 18 879 15 731
Amortization 8 389 6 317
Reported EBITDA 106 5,203 87 4,248
Adjustments:
Part reversal of provision booked in Q1 for
Voluntary Retirement Scheme (2 ) (94 )
Adjusted EBITDA 104 5,109 87 4,248
Adjusted PAT Reconciliation Q2 FY12 — ($) ( ) ($) ( )
Reported PAT 63 3,078 58 2,867
Adjustments:
Interest on Bonus Debentures 2 118
Part reversal of provision booked in Q1 for
Voluntary Retirement Scheme (2 ) (94 )
Tax normalizing adjustment (0 ) (4 )
Adjusted PAT 63 3,099 58 2,867

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Segmental Analysis

Global Generics

Revenues from Global Generics segment are at 16.1 billion ($329 million) in Q2 FY12 registering growth of 18% over previous year.

• Revenues from North America at 6.3 billion in Q2 FY12 versus 4.4 billion in Q2 FY11. Growth in USD terms of 45% was led by new product launches in the last twelve months and market share improvement in key products.

• 5 new products launched during the quarter, including limited competition products such as fondaparinux and fexofenadine pseudoephedrine D24 OTC.

• 24 products of our prescription portfolio feature among the Top 3 rank in market share (Source: IMS Sales Volumes July 2011).

• During the quarter, 4 ANDAs were filed. The cumulative ANDA filings as of 30 th September, 2011 are 177. A total of 76 ANDAs are pending for approval with the USFDA of which 40 are Para IVs and 11 are FTFs.

• Revenues in Russia & Other CIS markets at 3.4 billion in Q2 FY12 versus 2.8 billion in Q2 FY11, year-on-year growth of 23%.

• Revenues in Russia at 2.9 billion in Q2 FY12 versus 2.3 billion in Q2 FY11, year-on-year growth in USD terms of 30%, largely driven by volume growth in key brands.

• OTC portfolio growth of 33% over previous year; OTC sales at 25% of overall Russia sales.

• Dr. Reddy’s year-on-year secondary prescription sales growth at 20% versus industry’s growth of 10%. (Source: Pharmexpert August 2011 ). Dr. Reddy’s is ranked 12 th in market share.

• Revenues in Other CIS markets remained flat at 477 million in Q2 FY12.

• Revenues in India increased by 9% to 3.5 billion in Q2 FY12 versus 3.2 billion in Q2 FY11.

• 3 new products launched during the quarter.

• Biosimilar portfolio growth of 22% over previous year ; represents 6% to sales.

• Revenues from Europe at 2.1 billion in Q2 FY12, declined by 10% over previous year.

• Revenues from Germany declined by 27% to 1.2 billion in Q2 FY12 due to continuing impact of tenders.

• Revenues from Rest of Europe grew by 26% to 933 million in Q2 FY12 driven by new launches in UK and growth in out-licensing business.

Pharmaceutical Services and Active Ingredients (PSAI)

Revenues from PSAI are at 5.9 billion in Q2 FY 12 versus 4.6 billion in Q2 FY11, year-on-year increase of 28%.

• Growth in Active Ingredients business led by new product launches in Europe.

• Pharmaceutical Services business grew on account of improved customer order book status.

• During the quarter, 11 DMFs were filed globally, with 2 in US, 2 in Europe, 1 in Canada and 6 in rest of the markets. The cumulative DMF filings as of 30 th September 2011 are 506.

Income Statement Highlights:

• Gross profit at 12.2 billion ($249 million) in Q2 FY12, margin of 54% to revenues, marginal increase over previous year.

• Selling, General & Administration (SG&A) expenses including amortization at 7.2 billion ($147 million) increased by 26% over Q2 FY11. This increase is on account of a) higher freight costs both on account of increase in sales volumes as well as rate increases, b) inflation and year-on-year increments linked increase in manpower costs across businesses, c) incremental costs at Bristol and Shreveport manufacturing facilities in the US and d) the increase in the OTC-related selling and marketing costs in Russia and other CIS markets as compared to previous year.

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• R&D expenses at 1.5 billion ($30 million) in Q2 FY12, increase of 15% over Q2 FY11.

• Net Finance costs are at 50 million ($1 million) in Q2 FY 12 versus 35 million ($0.7 million) in Q2 FY11 The change is on account of :

• Net forex gain of 151 million ($3 million) versus net forex loss of 49 million ($1 million) in Q2 FY11.

• Net interest expense of 225 million ($5 million) in Q2 FY12 versus 5 million ($0.1 million) in Q2 FY11.

• Profit on sale of investments of 25 million ($0.5 million) in Q2 FY12 versus 19 million ($0.4 million) in Q2 FY11.

• Adjusted EBITDA of 5.1 billion ($104 million) in Q2 FY12, is at 23% of revenues with year-on-year growth of 20%.
• Adjusted Profit after Tax for Q2 FY12 is at 3.1 billion ($63 million), is at 14% of
revenues with year-on-year growth of 8%.
• Adjusted EPS for Q2 FY 12 is at 18.2 ($0.4) versus 16.9 ($0.3) in Q2 FY11.
• Capital expenditure for H1 FY12 is at 3.6 billion ($73 million).

Appendix 1: Key Balance Sheet Items (in millions)

Particulars As on 30th Sep 11 — ($) ( ) As on 30th Jun 11 — ($) ( )
Cash and cash equivalents 155 7,596 111 5,468
Trade receivables 419 20,568 349 17,136
Inventories 379 18,592 355 17,401
Property, plant and equipment 641 31,450 622 30,524
Goodwill and Other Intangible assets 308 15,115 304 14,921
Loans and borrowings (current & non-current) 638 31,303 488 23,940
Trade payables 182 8,940 172 8,433
Equity 980 48,081 997 48,902

Appendix 2: Q2 FY12 Revenue Mix by Segment (in millions)

($) ( ) % ($) ( ) % Growth %
Global Generics 329 16,136 71 279 13,667 73 18
North America 6,287 39 4,416 32 42
Europe 2,117 13 2,366 17 (10 )
India 3,459 21 3,160 23 9
Russia & Other CIS 3,380 21 2,751 20 23
RoW 893 6 974 7 (8 )
PSAI 121 5,933 26 94 4,617 25 28
North America 1,068 18 814 18 31
Europe 2,303 39 1,551 34 48
India 752 13 653 14 15
RoW 1,810 31 1,599 35 13
Others 12 610 3 9 420 2 45
Total 462 22,678 100 381 18,704 100 21

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Appendix 3: Q2 FY12 Revenue Mix by Geography (in millions)

($) ( ) % ($) ( ) % %
North America 159 7,777 34 111 5,464 29 42
Europe 92 4,536 20 84 4,102 22 11
India 86 4,210 19 78 3,813 20 10
Russia & Other CIS 69 3,380 15 56 2,751 15 23
Others 57 2,775 12 52 2,573 14 8
Total 462 22,678 100 381 18,704 100 21

Appendix 4: H1 FY12 Consolidated Income Statement

All figures in millions, except EPS All US dollar figures based on convenience translation rate of 1USD = 49.05

Particulars H1 FY12 — ($) ( ) % ($) ( ) % %
Revenue 866 42,462 100 724 35,535 100 19
Cost of revenues 402 19,701 46 339 16,635 47 18
Gross profit 464 22,761 54 385 18,900 53 20
Operating Expenses
Selling, general & administrative expenses 285 13,972 33 228 11,191 31 25
Research and development expenses 54 2,656 6 46 2,263 6 17
Other operating (income) / expense (8 ) (401 ) (1 ) (8 ) (404 ) (1 ) (1 )
Results from operating activities 133 6,533 15 119 5,850 16 12
Net finance (income) / expense 2 96 0 4 212 1 (55 )
Share of (profit) / loss of equity accounted investees (0 ) (17 ) (0 ) (0 ) (8 ) (0 ) 113
Profit / (loss) before income tax 132 6,455 15 115 5,647 16 14
Income tax (benefit) / expense 15 751 2 14 684 2 10
Profit / (loss) for the period 116 5,704 13 101 4,963 14 15
Diluted EPS 0.7 33.6 0.6 29.2

Appendix 5: H1 FY12 Profit Reconciliation (in millions)

Adjusted EBITDA Reconciliation H1 FY12 — ($) ( ) H1 FY11 — ($) ( )
PBT 132 6,455 115 5,647
Interest 9 446 (0 ) (3 )
Depreciation 35 1,708 29 1,416
Amortization 16 794 12 605
Reported EBITDA 192 9,404 156 7,665
Adjustments:
One-time charge of Voluntary Retirement Scheme 1 42
Adjusted EBITDA 193 9,445 156 7,665

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Adjusted PAT Reconciliation H1 FY12 — ($) ( ) ($) ( )
Reported PAT 116 5,704 101 4,963
Adjustments:
Interest on Bonus Debentures 5 236
One-time charge of Voluntary Retirement Scheme 1 42
Tax normalizing adjustment (7 ) (364 )
Adjusted PAT 115 5,618 101 4,963

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 business segments — 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. Focus markets include India, USA, Russia and CIS, Germany, UK, Venezuela, S. Africa, Romania, Australia 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:

Kedar Upadhye at [email protected] or on +91-40-66834297 Raghavender R at [email protected] or on +91-40-49002135 Milan Kalawadia (North America) at [email protected] or on +1-9082034931

Media:

Rajan S at [email protected] or on +91-40- 49002445

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

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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

Teva and Dr. Reddy’s announce launch of generic Zyprexa ® in the United States

Hyderabad, India, October 25, 2011:

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) and Dr. Reddy’s Laboratories (NYSE: RDY) announced today the commercial launch of Olanzapine Tablets, the generic version of Eli Lilly’s Zyprexa ® . Annual sales of Zyprexa ® were approximately $3.2 billion in the United States as of September 2011, based on IMS sales data.

Teva’s Olanzapine Tablets in 2.5 mg, 5 mg, 7.5 mg, 10 mg and 15 mg and Dr. Reddy’s Olanzapine Tablets in 20 mg have each been awarded a 180-day period of marketing exclusivity in the U.S. Dr. Reddy’s is supplying the 20 mg version of the product following an April 2011 commercialization, manufacture and supply agreement with Teva. In addition, as per the terms of the agreement, Dr. Reddy’s will launch their 2.5 mg, 5 mg, 7.5 mg, 10 mg ,15 mg and 20 mg of Olanzapine tablets upon expiration of the 180-day exclusivity period.

ZYPREXA ® is a trademark of Eli Lilly and Company

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, diabetes, 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

About TEVA

Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients. Headquartered in Israel, Teva is the world’s largest generic drug maker, with a global product portfolio of more than 1,300 molecules and a direct presence in about 60 countries. Teva’s branded businesses focus on CNS, oncology, pain, respiratory and women’s health therapeutic areas as well as biologics. Teva currently employs approximately 45,000 people around the world and reached $16.1 billion in net sales in 2010.

For more information please contact:

Investors and Financial Analysts :

Kedar Upadhye at [email protected] / +91-40-66834297 Raghavender R at [email protected] / +91-40-49002135 Milan Kalawadia (North America) at [email protected] / +1-908-203-4931

Media :

Rajan S at [email protected] / +91-40-49002445

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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.

By: /s/ Sandeep Poddar
Date: October 26, 2011 Name: Sandeep Poddar
Title: Company Secretary

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