SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

Form 6-K

 

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13A-16 OR 15D-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

 

For the Quarter Ended September 30, 2018

 

Commission File Number 1-15182

 

DR. REDDY’S LABORATORIES LIMITED

(Translation of registrant’s name into English)

 

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

Hyderabad, Telangana 500 034, India

+91-40-49002900

 

(Address of principal executive office)

 

Indicate by check mark whether the 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): 82-________.

 

 

 

 

 

 

QUARTERLY REPORT

Quarter Ended September 30, 2018

 

Currency of Presentation and Certain Defined Terms

 

In this Quarterly Report, references to “$” or “dollars” or “U.S.$” or “U.S. dollars” are to the legal currency of the United States, references to “Rs.” or “rupees” or “Indian rupees” or “INR” are to the legal currency of India, references to “MXN” are to the legal currency of Mexico, and references to “EUR” or “euros” are to the legal currency of the European Union. Our unaudited condensed consolidated interim financial statements are presented in Indian rupees and are prepared in accordance with International Accounting Standard 34, “Interim Financial Reporting” (“IAS 34”). Convenience translation into U.S. dollars with respect to our unaudited condensed consolidated interim financial statements is also presented. References to a particular “fiscal” year are to our fiscal year ended March 31 of such year. References to “ADSs” are to our American Depositary Shares. All references to “IAS” are to the International Accounting Standards, to “IASB” are to the International Accounting Standards Board, to “IFRS” are to International Financial Reporting Standards as issued by the IASB, to “SIC” are to the Standing Interpretations Committee and to "IFRIC" are to the International Financial Reporting Interpretations Committee.

 

References to “U.S. FDA” are to the United States Food and Drug Administration, to “NDAs” are to New Drug Applications, and to “ANDAs” are to Abbreviated New Drug Applications.

 

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. References to “EU” are to the European Union. All references to “we”, “us”, “our”, “DRL”, “Dr. Reddy’s” or the “Company” shall mean Dr. Reddy’s Laboratories Limited and its subsidiaries. “Dr. Reddy’s” is a registered trademark of Dr. Reddy’s Laboratories Limited in India. Other trademarks or trade names used in this Quarterly Report are trademarks registered in the name of Dr. Reddy’s Laboratories Limited or are pending before the respective trademark registries, unless otherwise specified. Market share data is based on information provided by IQVIA (formerly Quintiles IMS Holdings Inc.), a provider of market research to the pharmaceutical industry, unless otherwise stated.

 

Except as otherwise stated in this report, all convenience translations from Indian rupees to U.S. dollars are at the certified foreign exchange rate of U.S.$1.00 = Rs.72.54, as published by Federal Reserve Board of Governors on September 28, 2018. 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 Quarterly Report and no portion of such information is incorporated herein.

 

Forward-Looking and Cautionary Statement

 

IN ADDITION TO HISTORICAL INFORMATION, THIS QUARTERLY 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 SECTION TITLED “OPERATING AND FINANCIAL REVIEW, TREND INFORMATION” AND ELSEWHERE IN THIS REPORT. READERS ARE CAUTIONED NOT TO PLACE UNDUE RELIANCE ON THESE FORWARD-LOOKING STATEMENTS, WHICH REFLECT OUR ANALYSIS ONLY AS OF THE DATE HEREOF. IN ADDITION, READERS SHOULD CAREFULLY REVIEW THE INFORMATION IN OUR PERIODIC REPORTS AND OTHER DOCUMENTS FILED WITH AND/OR FURNISHED TO THE SECURITIES AND EXCHANGE COMMISSION (“SEC”) FROM TIME TO TIME.

 

 2 

 

 

TABLE OF CONTENTS

 

ITEM 1. FINANCIAL STATEMENTS 4
ITEM 2. OPERATING AND FINANCIAL REVIEW, TREND INFORMATION 38
ITEM 3. LIQUIDITY AND CAPITAL RESOURCES 47
ITEM 4. OTHER MATTERS 49
ITEM 5. EXHIBITS 50
SIGNATURES 51

 

 3 

 

  

ITEM 1. FINANCIAL STATEMENTS

 

DR. REDDY’S LABORATORIES LIMITED AND SUBSIDIARIES

UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION

(in millions, except share and per share data)

 

Particulars  Note  September 30, 2018   September 30, 2018   March 31, 2018 
      Convenience translation
(See Note 2(d))
         
ASSETS                  
Current assets                  
Cash and cash equivalents  4  U.S.$52   Rs.3,780   Rs.2,638 
Other investments  5   215    15,605    18,330 
Trade and other receivables      636    46,135    40,617 
Inventories  6   448    32,490    29,089 
Derivative financial instruments      5    347    103 
Tax assets      45    3,285    4,567 
Other current assets      181    13,139    14,301 
Total current assets without disposal group     U.S.$1,582   Rs.114,781   Rs.109,645 
Assets of disposal group held for sale  25   11    829    - 
Total current assets     U.S.$1,594   Rs.115,610   Rs.109,645 
Non-current assets                  
Property, plant and equipment     U.S.$781   Rs.56,640   Rs.57,869 
Goodwill  10   55    4,016    3,945 
Other intangible assets      652    47,274    44,665 
Trade and other receivables      3    182    169 
Investment in equity accounted investees      32    2,329    2,104 
Other investments  5   20    1,452    2,549 
Deferred tax assets      77    5,564    3,628 
Other non-current assets      16    1,167    1,030 
Total non-current assets     U.S.$1,635   Rs.118,624   Rs.115,959 
Total assets     U.S.$3,229   Rs.234,234   Rs.225,604 
LIABILITIES AND EQUITY                  
Current liabilities                  
Trade and other payables     U.S.$194   Rs.14,073   Rs.16,052 
Short-term borrowings  12   384    27,855    25,466 
Long-term borrowings, current portion  12   1    62    63 
Provisions      54    3,905    3,732 
Tax liabilities      15    1,084    1,530 
Derivative financial instruments      10    690    85 
Bank overdraft  4   0    8    96 
Other current liabilities      325    23,552    22,668 
Total current liabilities without disposal group     U.S.$982   Rs.71,229   Rs.69,692 
Liabilities of disposal group held for sale  25   1    77    - 
Total current liabilities     U.S.$983   Rs.71,306   Rs.69,692 
Non-current liabilities                  
Long-term borrowings  12  U.S.$380   Rs.27,597   Rs.25,089 
Deferred tax liabilities      10    694    730 
Provisions      1    54    53 
Other non-current liabilities      43    3,137    3,580 
Total non-current liabilities     U.S.$434   Rs.31,482   Rs.29,452 
Total liabilities     U.S.$1,417   Rs.102,788   Rs.99,144 
Equity                  
Share capital  15  U.S.$11   Rs.830   Rs.830 
Treasury shares  15   (1)   (64)   - 
Share premium      112    8,155    7,790 
Share based payment reserve      11    820    1,021 
Capital redemption reserve      2    173    173 
Retained earnings      1,647    119,449    113,865 
Other components of equity      29    2,083    2,781 
Total equity     U.S.$1,812   Rs.131,446   Rs.126,460 
Total liabilities and equity     U.S.$3,229   Rs.234,234   Rs.225,604 

 

The accompanying notes form an integral part of these unaudited condensed consolidated interim financial statements.

 

 4 

 

 

DR. REDDY’S LABORATORIES LIMITED AND SUBSIDIARIES

UNAUDITED CONDENSED CONSOLIDATED INTERIM INCOME STATEMENTS

(in millions, except share and per share data)

 

     

For the six months ended

September 30,

  

For the three months

ended September 30,

 
Particulars  Note  2018   2018   2017   2018   2017 
      Convenience
translation (See
Note 2(d))
                 
Revenues(1)  26 

U.S.$

1,036   Rs.75,185   Rs.68,619   Rs.37,978   Rs.35,460 
Cost of revenues      463    33,560    32,621    17,081    16,559 
Gross profit      574    41,625    35,998    20,897    18,901 
Selling, general and administrative expenses      337    24,478    22,795    12,372    11,032 
Research and development expenses      114    8,277    9,250    4,120    4,175 
Other income net  13   (13)   (944)   (308)   (641)   (114)
Total operating expenses      439    31,811    31,737    15,851    15,093 
Results from operating activities (A)      135    9,814    4,261    5,046    3,808 
Finance income      16    1,184    635    833    199 
Finance expense      (6)   (403)   (438)   (208)   (223)
Finance (expense)/income, net (B)  14   11    781    197    625    (24)
Share of profit of equity accounted investees, net of tax (C)      3    192    190    109    92 
Profit before tax [(A)+(B)+(C)]      149    10,787    4,648    5,780    3,876 
Tax expense  18   16    1,188    1,208    742    1,027 
Profit for the period    

U.S.$

132   Rs.9,599   Rs.3,440   Rs.5,038   Rs.2,849 
Earnings per share:                            
Basic earnings per share of Rs.5/- each    

U.S.$

0.80   Rs.57.83   Rs.20.75   Rs.30.35   Rs.17.18 
Diluted earnings per share of Rs.5/- each    

U.S.$

0.80   Rs.57.76   Rs.20.71   Rs.30.31   Rs.17.15 

 

The accompanying notes form an integral part of these unaudited condensed consolidated interim financial statements.

 

(1)Effective July 1, 2017, Goods and Services Tax (“GST”) was introduced in India. Following the principles of IFRS 15, revenues from operations are disclosed net of GST. For periods prior to July 1, 2017, the excise duty amount was recorded as part of revenues with a corresponding amount recorded in the cost of revenues. Accordingly, revenues and cost of revenues for the six months ended September 30, 2018 are not comparable with those of the previous period presented. Revenues for the six months ended September 30, 2017 include excise duty amounting to Rs.173.

 

 5 

 

 

DR. REDDY’S LABORATORIES LIMITED AND SUBSIDIARIES

UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE INCOME

(in millions, except share and per share data)

 

  

For the six months ended

September 30,

  

For the three months

ended September 30,

 
Particulars  2018   2018   2017   2018   2017 
   Convenience
translation
(See Note
2(d))
                 
Profit for the period 

U.S.$

132   Rs.9,599   Rs.3,440   Rs.5,038   Rs.2,849 
Other comprehensive income/(loss)                         
Items that will not be reclassified to the consolidated income statement:                         
Changes in the fair value of financial instruments 

U.S.$.

(6)  Rs.(456)  Rs.-   Rs.59   Rs.- 
Actuarial gains on post-employment benefit obligations   0    8    -    8    - 
Tax impact on above items   2    124    -    (16)   - 
Total of items that will not be reclassified subsequently to the consolidated income statement 

U.S.$.

(4)  Rs.(324)  Rs.-   Rs.51   Rs.- 
Items that will be reclassified subsequently to the consolidated income statement:                         
Changes in fair value of available for sale financial instruments  U.S.$-   Rs.-   Rs.(2,240)  Rs.-   Rs.(564)
Foreign currency translation adjustments   2    148    (118)   225    (11)
Foreign currency translation reserve re-classified to the income statement on disposal of foreign operation   (2)   (113)   -    (113)   - 
Effective portion of changes in fair value of cash flow hedges, net   (8)   (590)   (30)   (312)   (140)
Tax impact on above items   3    231    522    114    172 
Total of items that will be reclassified subsequently to the consolidated income statement 

U.S.$.

(4)  Rs.(324)  Rs.(1,866)  Rs.(86)  Rs.(543)
Other comprehensive loss for the period, net of tax 

U.S.$.

(9)  Rs.(648)  Rs.(1,866)  Rs.(35)  Rs.(543)
Total comprehensive income for the period 

U.S.$

123   Rs.8,951   Rs.1,574   Rs.5,003   Rs.2,306 

 

The accompanying notes form an integral part of these unaudited condensed consolidated interim financial statements.

 

 6 

 

 

DR. REDDY’S LABORATORIES LIMITED AND SUBSIDIARIES

UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CHANGES IN EQUITY

(in millions, except share and per share data)

 

   Share
capital
   Share
premium
   Treasury
shares
   Share-
based
payment
reserve
   Fair value
reserve
   Foreign
currency
translation
reserve
   Hedging
reserve
   Capital
redemption
reserve
  

Actuarial
gains
/(losses)

   Retained
earnings
   Total 
Balance as of April 1, 2018  Rs.830   Rs.7,790   Rs.-   Rs.1,021   Rs.(1,046)  Rs.4,184   Rs.45   Rs.173   Rs.(402)  Rs.113,865   Rs.126,460 
Adjustment on account of transition to IFRS 9(1)   -    -    -    -    (50)   -    -    -    -    (12)   (62)
Adjusted balance as of April 1, 2018 (A)  Rs.830   Rs.7,790   Rs.-   Rs.1,021   Rs.(1,096)(2)  Rs.4,184   Rs.45   Rs.173   Rs.(402)  Rs.113,853   Rs.126,398 
Profit for the period   -    -    -    -    -    -    -    -    -    9,599    9,599 
Net change in fair value of equity instruments, net of tax benefit of Rs.127   -    -    -    -    (329)   -    -    -    -    -    (329)
Foreign currency translation adjustments, net of tax benefit of Rs.14(3)   -    -    -    -    -    49    -    -    -    -    49 
Effective portion of changes in fair value of cash flow hedges, net of tax benefit of Rs.217   -    -    -    -    -    -    (373)   -    -    -    (373)
Actuarial gain/(loss) on post-employment benefit obligations, net of tax expense of Rs.3   -    -    -    -    -    -    -    -    5    -    5 
Total comprehensive income (B)  Rs.0   Rs.-   Rs.-   Rs.-   Rs.(329)  Rs.49   Rs.(373)  Rs.-   Rs.5   Rs.9,599   Rs.8,951 
Issue of equity shares on exercise of options   0    365    -    (365)   -    -    -    -    -    -    0 
Share-based payment expense   -    -    -    164    -    -    -    -    -    -    164 
Purchase of treasury shares   -    -    (64)   -    -    -    -    -    -    -    (64)
Dividend paid (including corporate dividend tax)   -    -    -    -    -    -    -    -    -    (4,003)   (4,003)
Total transactions with owners of the Company (C)  Rs.0   Rs.365   Rs.(64)  Rs.(201)  Rs.-   Rs.-   Rs.-   Rs.-   Rs.-   Rs.(4,003)  Rs.(3,903)
Balance as of September 30, 2018 [(A)+(B)+(C)]  Rs.830   Rs.8,155   Rs.(64)  Rs.820   Rs.(1,425)   Rs4,233   Rs.(328)  Rs.173   Rs.(397)  Rs.119,449   Rs.131,446 
Convenience translation  (See note 2(d))  U.S.$11  

U.S.$

112   U.S.$(1)  U.S.$11  

U.S.$.

(20)  U.S.$58  

U.S.$.

(5)  U.S.$2   U.S.$.(6)  U.S.$1,647   U.S.$1,812 
                                                        
Balance as of April 1, 2017 (D)  Rs.829   Rs.7,359   Rs.-   Rs.998   Rs.2,744   Rs.4,233   Rs.86   Rs.173   Rs.(429)  Rs.108,051   Rs.124,044 
Profit for the period   -    -    -    -    -    -    -    -    -    3,440    3,440 
Net change in fair value of available for sale financial instruments, net of tax benefit of Rs.534   -    -    -    -    (1,706)   -    -    -    -    -    (1,706)
Foreign currency translation adjustments, net of tax expense of Rs.23   -    -    -    -    -    (141)   -    -    -    -    (141)
Effective portion of changes in fair value of cash flow hedges, net of tax benefit of Rs.11   -    -    -    -    -    -    (19)   -    -    -    (19)
Total comprehensive income (E)  Rs.0   Rs.-   Rs.-   Rs.-   Rs.(1,706)  Rs.(141)  Rs.(19)  Rs.-   Rs.-   Rs.3,440   Rs.1,574 
Issue of equity shares on exercise of options   0    349    -    (349)   -    -    -    -    -    -    0 
Share-based payment expense   -    -    -    214    -    -    -    -    -    -    214 
Dividend paid (including corporate dividend tax)   -    -    -    -    -    -    -    -    -    (3,992)   (3,992)
Total transactions with owners of the Company (F)  Rs.0   Rs.349   Rs.-   Rs.(135)  Rs.-   Rs.-   Rs.-   Rs.-   Rs.-   Rs.(3,992)  Rs.(3,778)
Balance as of September 30, 2017 [(D)+(E)+(F)]  Rs.829   Rs.7,708   Rs.-   Rs.863   Rs.1,038   Rs.4,092   Rs.67   Rs.173   Rs.(429)  Rs.107,499   Rs.121,840 

 

The accompanying notes form an integral part of these unaudited condensed consolidated interim financial statements.

 

(1)Consists of mark to market gains on mutual funds amounting to Rs.50, offset by an impairment loss of Rs.62 on trade receivables. The net impact of Rs.12 was considered in retained earnings.

 

(2)Represents mark to market gain/(loss) on available-for-sale financial instruments (under IAS 39) recognized in other comprehensive income (“OCI”). The amount will be retained in OCI and will be re-classified to retained earnings only on disposal of these investments.
(3)Includes gain of Rs.113 re-classified from foreign currency translation reserve to the income statement on disposal of a foreign operation. Refer to Note 9 of these unaudited condensed consolidated interim financial statements for further details.

 

 7 

 

 

DR. REDDY’S LABORATORIES LIMITED AND SUBSIDIARIES

UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS

(in millions, except share and per share data) 

 

   For the six months ended September 30, 
Particulars  2018   2018   2017 
   Convenience
translation
(See Note 2(d))
         
Cash generated from operating activities:               
Profit for the period 

U.S.$

132   Rs.9,599   Rs.3,440 
Adjustments for:               
Income tax expense   16    1,188    1,208 
Realized and unrealized gains on investments   (3)   (221)   (371)
Depreciation and amortization   82    5,981    5,740 
Impairment loss on property, plant and equipment, and other intangible assets   2    127    - 
Inventory write-downs   22    1,577    1,586 
Allowance for credit loss and doubtful trade and other receivables   2    149    (11)
Profit on sale of property, plant and equipment and other intangible assets, net   (7)   (540)   (2)
Allowance for sales returns   22    1,578    1,367 
Share of profit of equity accounted investees   (3)   (192)   (190)
Exchange gain, net   (30)   (2,176)   (1,471)
Interest expense, net   1    43    231 
Equity settled share-based payment expense   2    164    214 
Changes in operating assets and liabilities:               
Trade and other receivables   (40)   (2,881)   (3,490)
Inventories   (69)   (5,005)   154 
Trade and other payables   (22)   (1,611)   326 
Other assets and other liabilities   (4)   (277)   (2,913)
    103    7,503    5,818 
Income tax paid   (25)   (1,797)   (1,090)
Net cash generated from operating activities 

U.S.$

79   Rs.5,706   Rs.4,728 
Cash flows from/(used in) investing activities:               
Purchase of property, plant and equipment   (51)   (3,668)   (5,570)
Proceeds from sale of property, plant and equipment, and other intangible assets   17    1,233    50 
Purchase of other intangible assets   (11)   (776)   (486)
Purchase of other investments   (505)   (36,637)   (24,619)
Proceeds from sale of other investments   553    40,119    24,955 
Interest and dividend received   4    266    214 
Net cash from/(used in) investing activities 

U.S.$

7   Rs.537   Rs.(5,456)
Cash flows used in financing activities:               
Proceeds from issuance of equity shares   0    0    0 
Repayment of short-term borrowings, net   (4)   (290)   (14,961)
Repayment of long-term borrowings   (1)   (42)   (74)
Proceeds from long-term borrowings   -    -    19,065 
Purchase of treasury shares   (1)   (64)   - 
Dividend paid (including corporate dividend tax)   (55)   (4,003)   (3,992)
Interest paid   (10)   (746)   (684)
Net cash used in financing activities 

U.S.$

(71)  Rs.(5,145)  Rs.(646)
Net increase/(decrease) in cash and cash equivalents   15    1,098    (1,374)
Effect of exchange rate changes on cash and cash equivalents   2    132    (5)
Cash and cash equivalents at the beginning of the period   35    2,542    3,779 
Cash and cash equivalents at the end of the period (See Note 4 for further details) 

U.S.$

52   Rs.3,772   Rs.2,400 

 

The accompanying notes form an integral part of these unaudited condensed consolidated interim financial statements.

 

 8 

 

 

DR. REDDY’S LABORATORIES LIMITED AND SUBSIDIARIES

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(in millions, except share and per share data and where otherwise stated)

 

1. Reporting entity

 

Dr. Reddy’s Laboratories Limited (the “parent company”), together with its subsidiaries and joint ventures (collectively, the “Company”), is a leading India-based pharmaceutical company headquartered in Hyderabad, Telangana, India. Through its three businesses - Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products – the Company offers a portfolio of products and services, including Active Pharmaceutical Ingredients (“APIs”), Custom Pharmaceutical Services (“CPS”), generics, biosimilars and differentiated formulations. The Company’s principal research and development facilities are located in the states of Telangana and Karnataka in India, Cambridge in the United Kingdom and Leiden in the Netherlands; its principal manufacturing facilities are located in the states of Telangana, Andhra Pradesh and Himachal Pradesh in India, Cuernavaca-Cuautla in Mexico, Mirfield in the United Kingdom, and Louisiana in the United States; and its principal markets are in India, Russia, the United States, Ukraine, and Germany. The Company’s shares trade on the Bombay Stock Exchange and the National Stock Exchange in India and on the New York Stock Exchange in the United States.

 

2. Basis of preparation of financial statements

 

a) Statement of compliance

 

These unaudited condensed consolidated interim financial statements (hereinafter referred to as “interim financial statements”) are prepared in accordance with IAS 34, “Interim Financial Reporting” as issued by the International Accounting Standards Board (“IASB”). They do not include all of the information required for a complete set of annual financial statements and should be read in conjunction with the audited consolidated financial statements and related notes included in the Company’s Annual Report on Form 20-F for the fiscal year ended March 31, 2018. These interim financial statements were authorized for issuance by the Company’s Board of Directors on November 01, 2018.

 

b) Significant accounting policies

 

The accounting policies applied by the Company in these interim financial statements are the same as those applied by the Company in its audited consolidated financial statements as at and for the year ended March 31, 2018 contained in the Company’s Annual Report on Form 20-F except for the changes to the accounting policies on adoption of IFRS 9, “Financial instruments”, and IFRS 15, “Revenue from Contracts with Customers”.

 

Impact of adoption of IFRS 9 and IFRS 15

 

IFRS 9, Financial Instruments

 

In July 2014, the IASB issued the final version of IFRS 9, “Financial instruments”. IFRS 9 significantly differs from IAS 39, “Financial Instruments: Recognition and Measurement”, and includes a logical model for classification and measurement, a single, forward-looking “expected loss” impairment model and a substantially-reformed approach to hedge accounting. The Company applied the modified retrospective method upon adoption of IFRS 9 on April 1, 2018. This method requires the recognition of the cumulative effect of initially applying IFRS 9 to retained earnings and not to restate prior years. The cumulative effect recorded at April 1, 2018 was a decrease to retained earnings of Rs.12.

 

Detailed below is the impact of the implementation of IFRS 9 on the Company.

 

Investment in mutual funds

 

The most significant impact to the Company, upon adoption of IFRS 9, relates to the treatment of the unrealized gains and losses from changes in fair value on investment in mutual funds. Investment in mutual funds, was previously classified as available-for-sale investments. The unrealized gains and losses which were previously recognized in the consolidated statement of other comprehensive income will now be recognized in the consolidated income statement. On transition to IFRS 9, the unrealized gain of Rs.50 previously recognized in other comprehensive income was transferred to retained earnings.

 

 9 

 

 

DR. REDDY’S LABORATORIES LIMITED AND SUBSIDIARIES

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(in millions, except share and per share data and where otherwise stated)

 

2. Basis of preparation of financial statements (continued)

 

b) Significant accounting policies (continued)

 

Investment in equity shares

 

All equity investments within the scope of IFRS 9 are measured at fair value. Equity instruments which are held for trading and contingent consideration recognized by an acquirer in a business combination to which IFRS 3 applies are classified as at fair value through profit and loss (“FVTPL”). For all other equity instruments, the Company may make an irrevocable election to present subsequent changes in the fair value through other comprehensive income (“FVTOCI”). The Company makes such election on an instrument by-instrument basis. The classification is made on initial recognition and is irrevocable.

 

The Company has elected the irrevocable option to record fair value movements on certain equity investments in the consolidated statement of other comprehensive income with no future reclassification of such gains and losses to the consolidated income statement. On transition to IFRS 9, an amount of Rs.1,096, representing the change in the fair value of equity instruments as on April 1, 2018, was retained in other comprehensive income and will be reclassified to retained earnings on sale of such instruments.

 

Impairment of trade receivables

 

In accordance with IFRS 9, the Company has implemented the expected credit loss (“ECL”) model for measurement and recognition of impairment loss on its trade receivables or any contractual right to receive cash or another financial asset that result from transactions that are within the scope of IFRS 15.

 

The Company follows a “simplified approach” which does not require the Company to track changes in credit risk but rather recognize impairment loss allowance based on lifetime ECLs at each reporting date, right from its initial recognition. For this purpose, the Company designed a provision matrix to determine impairment loss allowance on the portfolio of its trade receivables. The provision matrix is based on its historically observed default rates over the expected life of the trade receivables and is adjusted for forward-looking estimates. At every reporting date, the historical observed default rates are updated and changes in the forward-looking estimates are analyzed.

 

Hedge accounting

 

The new hedge accounting model introduced by the standard requires hedge accounting relationships to be based upon the Company’s own risk management strategy and objectives, and to be discontinued only when the relationships no longer qualify for hedge accounting. Based on the impact of the adoption assessment performed, the Company believes that its hedge relationships designated under IAS 39, “Financial Instruments: Recognition and Measurement”, will continue to be designated as such under the new hedge accounting requirements.

 

Tabulated below is the impact of the implementation of IFRS 9 on the financial position of the Company on the transition date:

 

   April 1, 2018   IFRS 9
adjustment
   Adjusted April
1, 2018
 
Current assets:               
Trade and other receivables  Rs.40,617   Rs.(87)  Rs.40,530 
Non-current assets:               
Deferred tax assets  Rs.3,628   Rs.25   Rs.3,653 
Equity:               
Retained earnings  Rs.113,865   Rs.(12)  Rs.113,853 
Other components of equity   2,781    (50)   2,731 

 

 10 

 

 

DR. REDDY’S LABORATORIES LIMITED AND SUBSIDIARIES

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(in millions, except share and per share data and where otherwise stated)

 

2. Basis of preparation of financial statements (continued)

 

b) Significant accounting policies (continued)

 

IFRS 15, Revenue from Contracts with Customers

 

In May 2014, the IASB issued IFRS 15, “Revenue from Contracts with Customers”. This comprehensive new standard supersedes IAS 18, “Revenue”, IAS 11, “Construction contracts” and related interpretations. The new standard amends revenue recognition requirements and establishes principles for reporting information about the nature, amount, timing and uncertainty of revenue and cash flows arising from contracts with customers.

 

The impacts of the adoption of the new standard are summarized below:

 

The Company’s revenue is derived from sales of goods, service income and income from licensing arrangements. Most of such revenue (approximately 97%) is generated from the sale of goods.

 

Sale of goods

 

Revenue from sales of goods is comprised of sale of generic and branded products and sale of active pharmaceutical ingredients and intermediates. Revenue from sale of goods is recognized where control is transferred to the Company’s customers at the time of shipment to or receipt of goods by the customers. There was no change in the point of recognition of revenue upon adoption of IFRS 15.

 

Service income

 

Service income, which primarily relates to revenue from contract research, is recognized as and when the underlying services are performed. There was no change in the point of recognition of revenue upon adoption of IFRS 15. Upfront non-refundable payments received under these arrangements continue to be deferred and are recognized over the expected period that related services are to be performed.

 

License fees

 

License fees primarily consist of income from the out-licensing of intellectual property, and other licensing and supply arrangements with various parties. Revenue from license fees is recognized when control transfers to the third party and the Company’s performance obligations are satisfied. The adoption of IFRS 15 did not significantly change the timing or amount of revenue recognized from these arrangements, nor did it change accounting for these royalty arrangements, as the standard’s royalty exception is applied for intellectual property licenses. Upfront non-refundable payments received under these arrangements continue to be deferred and are recognized over the expected period that related services are to be performed.

 

Profit share revenues and milestone payments

 

Revenues from sales of goods also include revenues from profit sharing arrangements with business partners for sales of the Company’s products in certain markets. Furthermore, the Company receives milestone payments related to out-licensing of the intellectual property. Under IFRS 15, the profit share amount is recognized only to the extent that it is highly probable that a significant reversal in the amount of profit share will not occur when the uncertainty associated with the profit share is subsequently resolved. The adoption of IFRS 15 did not significantly change the timing or amount of revenue recognized under these arrangements.

 

The Company applied the modified retrospective method upon adoption of IFRS 15 on April 1, 2018. This method requires the recognition of the cumulative effect of initially applying IFRS 15 to retained earnings and not to restate prior years.

 

Overall, the application of this standard did not have a material impact on the revenue streams from the sale of goods, service income, license fee, profit share revenues and milestone payments, and associated rebates and sales returns provision.

 

 11 

 

 

DR. REDDY’S LABORATORIES LIMITED AND SUBSIDIARIES

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(in millions, except share and per share data and where otherwise stated)

 

2. Basis of preparation of financial statements (continued)

 

c) Basis of measurement

 

These interim financial statements have been prepared in accordance with the historical cost convention and on an accrual basis, except for the following material items in the statement of financial position:

 

·derivative financial instruments are measured at fair value;
·certain financial assets are measured either at fair value or at amortized cost depending on the classification;
·employee defined benefit assets/(liabilities) are recognized as the net total of the fair value of plan assets, adjusted for actuarial gains/(losses) and the present value of the defined benefit obligation;
·long term borrowings, except obligations under finance leases, are measured at amortized cost using the effective interest rate method;
·share-based payments are measured at fair value; and
·investments in joint ventures are accounted for using the equity method.

 

d) Convenience translation

 

These interim financial statements have been prepared in Indian rupees. Solely for the convenience of the reader, these interim financial statements as of and for the three months ended September 30, 2018 have been translated into U.S. dollars at the certified foreign exchange rate of U.S.$1.00 = Rs.72.54, as published by the Federal Reserve Board of Governors on September 28, 2018. 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. Such convenience translation is not subject to review by the Company’s independent auditors.

 

e) Functional and presentation currency

 

These interim financial statements are presented in Indian rupees, which is the functional currency of the parent company. All financial information presented in Indian rupees has been rounded to the nearest million.

 

In respect of certain non-Indian subsidiaries that operate as marketing arms of the parent company in their respective countries/regions, the functional currency has been determined to be the functional currency of the parent company (i.e., the Indian rupee). The operations of these entities are largely restricted to importing of finished goods from the parent company in India, sales of these products in the foreign country and making of import payments to the parent company. The cash flows realized from sales of goods are available for making import payments to the parent company and cash is paid to the parent company on a regular basis. The costs incurred by these entities are primarily the cost of goods imported from the parent company. The financing of these subsidiaries is done directly or indirectly by the parent company.

 

In respect of subsidiaries whose operations are self-contained and integrated within their respective countries/regions, the functional currency has been generally determined to be the local currency of those countries/regions, unless use of a different currency is considered appropriate.

 

f) Use of estimates and judgments

 

The preparation of interim financial statements in conformity with IFRS requires management to make judgments, estimates and assumptions that affect the application of accounting policies and the reported amounts of assets, liabilities, income and expenses. Actual results may differ from these estimates. In preparing these interim financial statements, the significant judgments made by management in applying the Company’s accounting policies and the key sources of estimation uncertainty were the same as those that applied to the audited consolidated financial statements as at and for the year ended March 31, 2018.

 

 12 

 

 

DR. REDDY’S LABORATORIES LIMITED AND SUBSIDIARIES

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(in millions, except share and per share data and where otherwise stated)

 

2. Basis of preparation of financial statements (continued)

 

g) Recent accounting pronouncements

 

Standards issued but not yet effective and not early adopted by the Company

 

IFRS 16, Leases

 

In January 2016, the IASB issued a new standard, IFRS 16, “Leases”. The new standard brings most leases on-balance sheet for lessees under a single model, eliminating the distinction between operating and finance leases. Lessor accounting, however, remains largely unchanged and the distinction between operating and finance leases is retained. IFRS 16 supersedes IAS 17, “Leases”, and related interpretations and is effective for annual reporting periods beginning on or after January 1, 2019. Earlier adoption of IFRS 16 is permitted if IFRS 15, “Revenue from Contracts with Customers”, has also been applied.

 

Upon adoption, a portion of the annual operating lease expense, which is currently fully recognized as functional expense, will be recognized as finance expense. Further, a portion of the annual lease payments recognized in the cash flow statement as reduction of lease liability will be recognized as outflow from financing activities, which are currently fully recognized as an outflow from operating activities.

 

The undiscounted and non-cancellable operating lease commitments of Rs.1,929 and Rs.1,710 as at March 31, 2018 and 2017, respectively, as disclosed in Note 27 of Form 20-F as of March 31, 2018, provide an indicator of the impact of implementation of IFRS 16 on the consolidated financial statements of the Company. Accordingly, the Company believes that the adoption of IFRS 16 will not have a material impact on its consolidated financial statements.

 

IFRIC 23, Uncertainty over Income Tax Treatments

 

On June 7, 2017, the IFRS Interpretations Committee issued IFRIC 23, which clarifies how the recognition and measurement requirements of IAS 12 “Income Taxes”, are applied where there is uncertainty over income tax treatments.

 

IFRIC 23 explains how to recognize and measure deferred and current income tax assets and liabilities where there is uncertainty over a tax treatment. An uncertain tax treatment is any tax treatment applied by an entity where there is uncertainty over whether that treatment will be accepted by the applicable tax authority. For example, a decision to claim a deduction for a specific expense or not to include a specific item of income in a tax return is an uncertain tax treatment if its acceptability is uncertain under applicable tax law. The interpretation provides specific guidance in several areas where previously IAS 12 was silent. IFRIC 23 applies to all aspects of income tax accounting where there is an uncertainty regarding the treatment of an item, including taxable profit or loss, the tax bases of assets and liabilities, tax losses and credits and tax rates.

 

The interpretation is effective for annual reporting periods beginning on or after January 1, 2019. Earlier application is permitted. An entity can, on initial application, elect to apply this interpretation either:

 

·retrospectively applying IAS 8, “Accounting Policies, Changes in Accounting Estimates and Errors”, if possible without the use of hindsight; or

 

·retrospectively, with the cumulative effect of initially applying the interpretation recognized at the date of initial application as an adjustment to the opening balance of retained earnings (or other component of equity, as appropriate).

 

The Company is in the process of evaluating the impact of IFRIC 23 on the consolidated financial statements.

 

 13 

 

 

DR. REDDY’S LABORATORIES LIMITED AND SUBSIDIARIES

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(in millions, except share and per share data and where otherwise stated)

 

3. Segment reporting

 

The Chief Operating Decision Maker (“CODM”) evaluates the Company’s performance and allocates resources based on an analysis of various performance indicators by operating segments. The CODM reviews revenue and gross profit as the performance indicator for all of the operating segments, and does not review the total assets and liabilities of an operating segment. The Chief Executive Officer is the CODM of the Company.

 

The Company’s reportable operating segments are as follows:

 

Global Generics;

Pharmaceutical Services and Active Ingredients (“PSAI”); and

Proprietary Products.

 

Global Generics. This segment consists of the Company’s business of manufacturing and marketing prescription and over-the-counter finished pharmaceutical products ready for consumption by the patient, marketed under a brand name (branded formulations) or as generic finished dosages with therapeutic equivalence to branded formulations (generics). This segment includes the operations of the Company’s biologics business.

 

Pharmaceutical Services and Active Ingredients. This segment consists of the Company’s business of manufacturing and marketing active pharmaceutical ingredients and intermediates, also known as “API” or bulk drugs, which are the principal ingredients for finished pharmaceutical products. Active pharmaceutical ingredients and intermediates become finished pharmaceutical products when the dosages are fixed in a form ready for human consumption such as a tablet, capsule or liquid using additional inactive ingredients. This segment also includes the Company’s contract research services business and the manufacture and sale of active pharmaceutical ingredients and steroids in accordance with the specific customer requirements.

 

Proprietary Products. This segment consists of the Company’s business that focuses on the research, development, and manufacture of differentiated formulations. These products fall within the dermatology and neurology therapeutic areas and are marketed and sold through Promius® Pharma, LLC.

 

Others. This segment consists of the operations of the Company’s wholly-owned subsidiary, Aurigene Discovery Technologies Limited, a discovery stage biotechnology company developing novel and best-in-class therapies in the fields of oncology and inflammation and which works with established pharmaceutical and biotechnology companies in early-stage collaborations, bringing drug candidates from hit generation to pre-clinical development.

 

The measurement of each segment’s revenues and expenses is consistent with the accounting policies that are used in preparation of the Company’s consolidated financial statements.

 

 14 

 

 

DR. REDDY’S LABORATORIES LIMITED AND SUBSIDIARIES

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(in millions, except share and per share data and where otherwise stated)

 

3. Segment reporting (continued)

 

Information about segments:  For the six months ended September 30, 2018   For the six months ended September 30, 2017 
Segments  Global
Generics
   PSAI   Proprietary
Products
   Others   Total   Global
Generics
   PSAI   Proprietary
Products
   Others   Total 
Revenues(1)  Rs.61,172   Rs.11,438   Rs.1,502   Rs.1,073   Rs.75,185   Rs.56,073   Rs.10,305   Rs.1,260   Rs.981   Rs.68,619 
Gross profit  Rs.36,867   Rs.2,882   Rs.1,247   Rs.629   Rs.41,625   Rs.32,772   Rs.1,640   Rs.1,051   Rs.535   Rs.35,998 
Selling, general and administrative expenses                       24,478                        22,795 
Research and development expenses                       8,277                        9,250 
Other income, net                       (944)                       (308)
Results from operating activities                      Rs.9,814                       Rs.4,261 
Finance income, net                       781                        197 
Share of profit of equity accounted investees, net of tax                       192                        190 
Profit before tax                      Rs.10,787                       Rs.4,648 
Tax expense                       1,188                        1,208 
Profit for the period                       9,599                       Rs.3,440 

 

(1)Revenues for the six months ended September 30, 2018 and 2017 do not include inter-segment revenues from the PSAI segment to the Global Generics segment, which amount to Rs.3,114 and Rs.2,695, respectively.

 

Information about segments:  For the three months ended September 30, 2018   For the three months ended September 30, 2017 
Segments  Global
Generics
   PSAI   Proprietary
Products
   Others   Total   Global
Generics
   PSAI   Proprietary
Products
   Others   Total 
Revenues(2)  Rs.30,536   Rs.6,029   Rs.776   Rs.637   Rs.37,978   Rs.28,618   Rs.5,654   Rs.748   Rs.440   Rs.35,460 
Gross profit  Rs.18,111   Rs.1,697   Rs.653   Rs.436   Rs.20,897   Rs.16,936   Rs.1,107   Rs.633   Rs.225   Rs.18,901 
Selling, general and administrative expenses                       12,372                        11,032 
Research and development expenses                       4,120                        4,175 
Other income, net                       (641)                       (114)
Results from operating activities                      Rs.5,046                       Rs.3,808 
Finance (expense)/income, net                       625                        (24)
Share of profit of equity accounted investees, net of tax                       109                        92 
Profit before tax                      Rs.5,780                       Rs.3,876 
Tax expense                       742                        1,027 
Profit for the period                      Rs.5,038                       Rs.2,849 

 

(2)Revenues for the three months ended September 30, 2018 and 2017 do not include inter-segment revenues from the PSAI segment to the Global Generics segment, which amount to Rs.1,628 and Rs.1,456, respectively.

 

 15 

 

  

DR. REDDY’S LABORATORIES LIMITED AND SUBSIDIARIES

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(in millions, except share and per share data and where otherwise stated)

 

3. Segment reporting (continued)

 

Analysis of revenues by geography:

 

The following table shows the distribution of the Company’s revenues by country, based on the location of the customers:

 

   For the six months ended
September 30,
   For the three months ended
September 30,
 
Country  2018   2017   2018   2017 
India  Rs.14,568   Rs.12,881   Rs.7,747   Rs.6,806 
United States   33,888    32,492    16,180    16,191 
Russia   7,581    6,679    3,793    3,218 
Others   19,148    16,567    10,258    9,245 
   Rs.75,185   Rs.68,619   Rs.37,978   Rs.35,460 

 

4. Cash and cash equivalents

 

Cash and cash equivalents consist of the following:

 

   As of 
   September 30, 2018   March 31, 2018 
Cash balances  Rs.2   Rs.2 
Balances with banks   2,168    1,454 
Term deposits with banks (original maturities up to 3 months)   1,610    1,182 
Cash and cash equivalents in the statement of financial position  Rs.3,780   Rs.2,638 
Bank overdrafts used for cash management purposes   8    96 
Cash and cash equivalents in the statement of cash flow  Rs.3,772   Rs.2,542 
Restricted cash balances included above          
Balance in unclaimed dividend and debenture interest account  Rs.101   Rs.72 
Other restricted cash balances   5    14 

 

 16 

 

 

DR. REDDY’S LABORATORIES LIMITED AND SUBSIDIARIES

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(in millions, except share and per share data and where otherwise stated)

 

5. Other investments

 

Other investments primarily consist of investments in units of mutual funds, equity securities, bonds, commercial paper and term deposits (i.e., certificates of deposit having an original maturity period exceeding 3 months). The details of such investments as of September 30, 2018 and March 31, 2018 were as follows:

 

   As of September 30, 2018   As of March 31, 2018 
   Cost   Unrealized
gain/(loss)
   Fair value/
amortized
cost(2)
   Cost   Unrealized
gain/(loss)
   Fair value /
amortized
cost(2)
 
In units of mutual funds  Rs.8,112   Rs.103   Rs.8,215   Rs.14,703   Rs.75   Rs.14,778 
In equity securities(1)   2,703    (1,965)   738    2,703    (1,508)   1,195 
In bonds   7,312    -    7,312    4,633    -    4,633 
In commercial paper   232    -    232    232    -    232 
Term deposits   538    -    538    41    -    41 
Others   22    -    22    -    -    - 
   Rs.18,919   Rs.(1,862)  Rs.17,057   Rs.22,312   Rs.(1,433)  Rs.20,879 
Current portion                              
In units of mutual funds  Rs.8,112   Rs.103   Rs.8,215   Rs.14,703   Rs.75   Rs.14,778 
In bonds   6,621    -    6,621    3,279    -    3,279 
In commercial paper   232    -    232    232    -    232 
Term deposits   537    -    537    41    -    41 
   Rs.15,502   Rs.103   Rs.15,605   Rs.18,255   Rs.75   Rs.18,330 
Non-current portion                              
In equity securities(1)  Rs.2,703   Rs.(1,965)  Rs.738   Rs.2,703   Rs.(1,508)  Rs.1,195 
In bonds   691    -    691    1,354    -    1,354 
Term deposits   1    -    1    -    -    - 
Others   22    -    22    -    -    - 
   Rs.3,417   Rs.(1,965)  Rs.1,452   Rs.4,057   Rs.(1,508)  Rs.2,549 

 

(1)Primarily represents the shares of Curis, Inc. Refer to Note 22 of these interim financial statements for further details.

 

(2)Interest accrued but not due on bonds, commercial paper and term deposits with banks is included in other assets.

 

The foregoing investments are valued as follows:

 

Type of Investment   Measurement of Value
Investments in units of mutual funds   Fair value through profit and loss
Investments in equity securities   Fair value through other comprehensive income
Investments in bonds, commercial paper, term deposits and others   Amortized cost

 

 17 

 

 

DR. REDDY’S LABORATORIES LIMITED AND SUBSIDIARIES

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(in millions, except share and per share data and where otherwise stated)

 

6. Inventories

 

Inventories consist of the following:

 

   As of 
   September 30, 2018   March 31, 2018 
Raw materials  Rs.8,204   Rs.7,294 
Packing materials, stores and spares   2,274    2,394 
Work-in-progress   7,225    7,175 
Finished goods   14,787    12,226 
   Rs.32,490   Rs.29,089 

 

Details of inventories recognized in consolidated income statement:

 

   For the six months ended
September 30,
   For the three months ended
September 30,
 
   2018   2017   2018   2017 
Raw materials, stores and spares, and changes in finished goods and work in progress  Rs.17,680   Rs.14,889   Rs.9,201   Rs.7,859 
Inventory write-downs   1,577    1,586    761    868 

 

7. Hedges of foreign currency exchange rate risks

 

The Company is exposed to exchange rate risk that arises from its foreign exchange revenues and expenses, primarily in U.S. dollars, U.K. pounds sterling, Russian roubles and Euros, and foreign currency debt in U.S. dollars, Russian roubles, Mexican pesos, Ukrainian hryvnias and Euros. The Company uses forward, option and currency swap contracts (collectively, “derivatives”) to mitigate its risk of changes in foreign currency exchange rates. The Company also uses non-derivative financial instruments, such as foreign currency borrowings, as part of its foreign currency exposure risk mitigation strategy.

 

Details of gain/(loss) recognized in respect of derivative contracts

 

   For the six months ended
September 30,
   For the three months ended
September 30,
 
   2018   2017   2018   2017 
Net loss recognized in finance costs in respect of foreign exchange derivative contracts  Rs.(1,026)  Rs.(107)  Rs.(503)  Rs.(189)
Net loss recognized in equity in respect of hedges of highly probable forecast transactions   (590)   (30)   (312)   (140)
Net gain/(loss) recognized as component of revenue   (255)   321    (223)   188 

 

The net carrying amount of the Company’s “hedging reserve” as a component of equity before adjusting for tax impact was a loss of Rs.540 as at September 30, 2018, as compared to a gain of Rs.49 as at March 31, 2018.

 

8. Financial instruments

 

Non-derivative financial instruments

 

Non-derivative financial instruments consist of investments in mutual funds, bonds, equity and debt securities, trade receivables, cash and cash equivalents, loans and borrowings, and trade payables.

 

Derivative financial instruments

 

The Company uses derivative contracts like forwards, options and interest rate swaps to mitigate its risk of changes in foreign currency exchange rates and interest rates.

 

 18 

 

 

DR. REDDY’S LABORATORIES LIMITED AND SUBSIDIARIES

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(in millions, except share and per share data and where otherwise stated)

 

8. Financial instruments (continued)

 

The carrying value and fair value of financial instruments as at September 30, 2018 and March 31, 2018 were as follows:

 

   As of September 30, 2018   As of March 31, 2018 
   Total carrying
value
   Total fair
value
   Total carrying
value
   Total fair
value
 
Assets:                    
Cash and cash equivalents  Rs.3,780   Rs.3,780   Rs.2,638   Rs.2,638 
Other investments(1)   17,057    17,057    20,879    20,879 
Trade and other receivables   46,317    46,317    40,786    40,786 
Derivative financial instruments   347    347    103    103 
Other assets(2)   2,520    2,520    2,273    2,273 
Total  Rs.70,021   Rs.70,021   Rs.66,679   Rs.66,679 
Liabilities:                    
Trade and other payables  Rs.14,073   Rs.14,073   Rs.16,052   Rs.16,052 
Derivative financial instruments   690    690    85    85 
Long-term borrowings   27,659    27,659    25,152    25,152 
Short-term borrowings   27,855    27,855    25,466    25,466 
Bank overdraft   8    8    96    96 
Other liabilities and provisions(3)   21,659    21,659    20,712    20,712 
Total  Rs.91,944   Rs.91,944   Rs.87,563   Rs.87,563 

 

(1)Interest accrued but not due on investments is included in other assets.

 

(2)Other assets that are not financial assets (such as receivables from statutory authorities, export benefit receivables, prepaid expenses, advances paid and certain other receivables) of Rs.11,786 and Rs.13,058 as of September 30, 2018 and March 31, 2018, respectively, are not included.

 

(3)Other liabilities and provisions that are not financial liabilities (such as statutory dues payable, deferred revenue, advances from customers and certain other accruals) of Rs.8,989 and Rs.9,321 as of September 30, 2018 and March 31, 2018, respectively, are not included.

 

Fair value hierarchy

 

Level 1 - Quoted prices (unadjusted) in active markets for identical assets or liabilities.

Level 2 - Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly (i.e., as prices) or indirectly (i.e., derived from prices).

Level 3 - Inputs for the assets or liabilities that are not based on observable market data (unobservable inputs).

 

The following table presents the fair value hierarchy of assets and liabilities measured at fair value on a recurring basis as of September 30, 2018:

 

Particulars  Level 1   Level 2   Level 3   Total 
Investments in units of mutual funds  Rs.8,215   Rs.-   Rs.-   Rs.8,215 
Investment in equity securities   738    -    -    738 
Derivative financial instruments - net gain/(loss) on outstanding foreign exchange forward, option and swap contracts and interest rate swap contracts(1)   -    (343)   -    (343)

 

 19 

 

 

DR. REDDY’S LABORATORIES LIMITED AND SUBSIDIARIES

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(in millions, except share and per share data and where otherwise stated)

 

8. Financial instruments (continued)

 

The following table presents the fair value hierarchy of assets and liabilities measured at fair value on a recurring basis as of March 31, 2018:

 

Particulars  Level 1   Level 2   Level 3   Total 
Available for sale - Financial asset - Investments in units of mutual funds  Rs.14,778   Rs.-   Rs.-   Rs.14,778 
Available for sale - Financial asset - Investment in equity securities   1,195    -    -    1,195 
Derivative financial instruments – net gain/(loss) on outstanding foreign exchange forward, option and swap contracts and interest rate swap contracts(1)   -    18    -    18 

 

(1)The Company enters into derivative contracts with various counterparties, principally financial institutions and banks. Derivatives valued using valuation techniques with market observable inputs are mainly interest rate swaps, foreign exchange forward option and swap contracts. The most frequently applied valuation techniques include forward pricing, swap pricing models and Black-Scholes-Merton models (for option valuation), using present value calculations. The models incorporate various inputs including foreign exchange forward rates, interest rate curves and forward rate curves.

 

As at September 30, 2018 and March 31, 2018, the changes in counterparty credit risk had no material effect on the hedge effectiveness assessment for derivatives designated in hedge relationships and other financial instruments recognized at fair value.

 

9. Property, plant and equipment

 

Acquisitions and disposals

 

   For the six months ended
September 30,
   For the year
ended
 
   2018   2017   March 31, 2018 
Cost of assets acquired during the period  Rs.3,242   Rs.4,709   Rs.8,894 
Net book value of assets disposed of during the period   424    48    157 
Impairment loss recognized during the period (1)   94    -    - 
Loss/(gain) on disposal during the period (2)   (124)   (2)   55 
Assets classified as disposal group (Refer to Note 25)   426    -    - 

 

(1)During the three months ended June 30, 2018, the Company entered into an agreement with Neopharma Inc. for the sale of its formulations manufacturing facility and related assets in Bristol, Tennessee which formed part of its Global generics segment. Consequent to this, the property, plant and equipment of this facility was measured at lower of the carrying value and fair value less costs to sell. Accordingly, an amount of Rs.94 was recorded as an impairment loss for the three months ended June 30, 2018.

 

(2)During the three months ended September 30, 2018, the sale formalities were completed and the Company sold all of the issued and outstanding membership interests in Dr. Reddy’s Laboratories Tennessee, LLC and certain related assets. The aforesaid sale resulted in a gain on disposal of Rs.110, which was recognized under the heading “other (income)/expense, net” as gain on disposal of assets. The gain on disposal includes Rs.113 of foreign currency translation reserve reclassified to the income statement on disposal of foreign operation.

 

Depreciation expense

 

   For the six months
ended September 30,
   For the three months
ended September 30,
 
   2018   2017   2018   2017 
Cost of revenues  Rs.3,197   Rs.3,159   Rs.1,581   Rs.1,606 
Selling, general and administrative expenses   382    383    193    190 
Research and development expenses   574    544    259    282 
   Rs.4,153   Rs.4,086   Rs.2,033   Rs.2,078 

 

Capital commitments

 

As of September 30, 2018 and March 31, 2018, the Company was committed to spend Rs.2,282 and Rs.3,788, respectively, under agreements to purchase property, plant and equipment. This amount is net of capital advances paid in respect of such purchase commitments.

 

 20 

 

 

DR. REDDY’S LABORATORIES LIMITED AND SUBSIDIARIES

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(in millions, except share and per share data and where otherwise stated)

 

10. Goodwill

 

Goodwill arising on business combinations is not amortized but is tested for impairment at least annually, or more frequently if there is any indication that the cash generating unit to which goodwill is allocated is impaired.

 

The following table presents goodwill as at September 30, 2018 and March 31, 2018:

 

   As at 
   September 30, 2018   March 31, 2018 
Opening balance, gross  Rs.20,219   Rs.20,026 
Effect of translation adjustments   71    193 
Impairment loss(1)    (16,274)   (16,274)
Closing balance  Rs.4,016   Rs.3,945 

 

(1)The impairment loss of Rs.16,274 includes Rs.16,003 pertaining to the Company’s German subsidiary, betapharm Arzneimittel GmbH, which is part of the Company’s Global Generics segment. This impairment loss was recorded during the years ended March 31, 2009 and 2010.

 

11. Other intangible assets

 

   For the six months ended
September 30,
   For the year ended 
   2018   2017   March 31, 2018 
Additions during the period  Rs.1,130   Rs.1,935   Rs.2,605 
Net book value of assets disposed of during the period   365    -    - 
Gain on disposal during the period   (416)   -    - 
Impairment loss recognized during the period   33    -    53 

 

Gain on disposal of assets includes an amount of Rs.354 representing the profit on sale of an intangible asset forming part of the Company’s Proprietary products segment.

 

Amortization of other intangible assets

 

   For the six months ended
September 30,
   For the three months
ended September 30,
 
   2018   2017   2018   2017 
Selling, general and administrative expenses  Rs.1,628   Rs.1,458   Rs.863   Rs.760 
Cost of revenues   139    130    71    70 
Research and development expenses   61    66    31    33 
   Rs.1,828   Rs.1,654   Rs.965   Rs.863 

 

Details of significant separately acquired intangible assets as at September 30, 2018:

 

Particulars of the asset  Acquired from  Carrying cost 
ANDAs  Teva and an affiliate of Allergan  Rs.25,773 
Select portfolio of assets  UCB India Private Limited and affiliates   5,829 
Intellectual property rights relating to PPC-06  Xenoport, Inc   3,631 
Habitrol® brand  Novartis Consumer Health Inc.   2,860 
Beta brand  -   1,465 
Commercialization rights for an anti-cancer biologic agent  Eisai Company Limited   1,796 
Intellectual property rights relating to Xeglyze™ lotion  Hatchtech Pty Limited   1,124 
Brands  Ducere Pharma LLC   836 
Intellectual property rights relating to fondaparinux sodium  Alchemia Limited   355 
ANDAs  Gland Pharma Limited   335 

 

 21 

 

 

DR. REDDY’S LABORATORIES LIMITED AND SUBSIDIARIES

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(in millions, except share and per share data and where otherwise stated)

 

12. Loans and borrowings

 

Short-term borrowings

 

Short-term borrowings primarily consist of “pre-shipment credit” drawn by the parent company and other unsecured loans drawn by certain of its subsidiaries in Switzerland, Germany, the United States, Russia, Mexico and Ukraine.

 

Short-term borrowings consist of the following:

 

   As at 
   September 30, 2018   March 31, 2018 
Pre-shipment credit  Rs.20,224   Rs.21,008 
Other foreign currency borrowings   7,631    4,458 
   Rs.27,855   Rs.25,466 

 

The interest rate profile of short-term borrowings from banks is given below:

 

  As at
  September 30, 2018   March 31, 2018
  Currency(1)   Interest Rate(2)   Currency   Interest Rate
Pre-shipment credit USD   1 Month LIBOR + 01  to 50 bps   USD   1 Month LIBOR + (30) to 30 bps
  -   -   INR   6.00%
  -   -   RUB   6.75%
Other foreign currency borrowings USD   1 Month LIBOR + 65 to 85 bps   USD   1 Month/3 Months LIBOR + 65 to 85 bps
  -   -   RUB   8.20%
  UAH   21.50%   UAH   18.00%
  MXN   TIIE + 1.25%   -   -

 

(1)“INR” means Indian rupees, “RUB” means Russian roubles, “MXN” means Mexican pesos and “UAH” means Ukrainian hryvnia.

 

(2)“LIBOR” means the London Inter-bank Offered Rate and “TIIE” means the Equilibrium Inter-banking Interest Rate (Tasa de Interés Interbancaria de Equilibrio).

 

Long-term borrowings

 

Long-term borrowings consist of the following:

 

   As at 
   September 30,
2018
   March 31,
2018
 
Foreign currency borrowing by the parent company  Rs.5,430   Rs.4,880 
Foreign currency borrowing by the Swiss Subsidiary   18,015    16,185 
Foreign currency borrowing by the German Subsidiary   3,527    3,394 
Obligations under finance leases   687    693 
   Rs.27,659   Rs.25,152 
Current portion          
Obligations under finance leases  Rs.62   Rs.63 
   Rs.62   Rs.63 
Non-current portion          
Foreign currency borrowing by the parent company  Rs.5,430   Rs.4,880 
Foreign currency borrowing by the Swiss Subsidiary   18,015    16,185 
Foreign currency borrowing by the German Subsidiary   3,527    3,394 
Obligations under finance leases   625    630 
   Rs.27,597   Rs.25,089 

 

The terms “Swiss Subsidiary” and “German Subsidiary”, as used in the above table, are defined below.

 

 22 

 

  

DR. REDDY’S LABORATORIES LIMITED AND SUBSIDIARIES

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(in millions, except share and per share data and where otherwise stated)

 

12. Loans and borrowings (continued)

 

Long-term borrowings (continued)

 

Long-term bank loan of the parent company

 

During the year ended March 31, 2014, the Company borrowed U.S.$150. The Company was required to repay the loan in five equal quarterly installments commencing at the end of the 54th month and continuing until the end of the 66th month from August 12, 2013. During the three months ended December 31, 2016, the Company entered into a financing arrangement with certain financial institutions to refinance the aforementioned borrowing of U.S.$150.

 

The Company repaid U.S.$75 of this loan on November 28, 2016, and is required to repay the U.S.$75 balance of the loan in 3 equal installments at the end of the 40th month, 43rd month and 46th month after the date the loan was refinanced.

 

Long-term bank loan of subsidiary companies

 

During the six months ended September 30, 2017, the Company incurred long-term borrowings of U.S.$250 in Dr. Reddy’s Laboratories, SA, one of the Company’s subsidiaries in Switzerland (the “Swiss Subsidiary”), and EUR 42 in Reddy Holding GmbH, one of the Company’s subsidiaries in Germany (the “German Subsidiary”). The aforesaid loans are repayable over a 36 month period commencing at the end of the 24th month and continuing through the 60th month following the date of the loan agreement.

 

All the foregoing loan agreements impose various financial covenants on the Company. As of September 30, 2018, the Company was in compliance with all such financial covenants.

 

The interest rate profiles of long-term borrowings (other than obligations under finance leases) as at September 30, 2018 and March 31, 2018 were as follows:

 

  As at
  September 30, 2018   March 31, 2018
  Currency   Interest Rate   Currency   Interest Rate
Foreign currency borrowings USD   LIBOR + 70 to 105 bps   USD   LIBOR + 45 to 82.7 bps
  EUR   0.81%   EUR   0.81%

 

Undrawn lines of credit from banks

 

The Company had undrawn lines of credit of Rs.31,120 and Rs.24,046 as of September 30, 2018 and March 31, 2018, respectively, from its banks for working capital requirements. The Company has the right to draw upon these lines of credit based on its working capital requirements.

 

13. Other income, net

 

Other (income)/expense, net consists of the following:

 

   For the six months
ended September 30,
   For the three months
ended September 30,
 
   2018   2017   2018   2017 
Gain on sale/disposal of property, plant and equipment and other intangibles, net(1)  Rs.(540)  Rs.(2)  Rs.(472)  Rs.(6)
Sale of spent chemicals   (190)   (133)   (97)   (74)
Scrap sales   (97)   (74)   (56)   (42)
Miscellaneous income, net   (117)   (99)   (16)   8 
   Rs.(944)  Rs.(308)  Rs.(641)  Rs.(114)

 

(1)Refer to Note 9 and Note 11 of these interim financial statements for further details.

 

 23 

 

 

DR. REDDY’S LABORATORIES LIMITED AND SUBSIDIARIES

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(in millions, except share and per share data and where otherwise stated)

  

14. Finance income/(expense), net

 

Finance income/(expense), net consists of the following:

 

   For the six months ended
September 30,
   For the three months ended
September 30,
 
   2018   2017   2018   2017 
Interest income  Rs.360   Rs.207   Rs.227   Rs.64 
Profit on sale of units of mutual funds   182    371    80    88 
Unrealized gain measured at FVTPL on units of mutual funds   39    -    33    - 
Foreign exchange gain   603    57    493    47 
Finance income (A)  Rs.1,184   Rs.635   Rs.833   Rs.199 
Interest expense   (403)   (438)   (208)   (223)
Finance expense (B)  Rs.(403)  Rs.(438)  Rs.(208)  Rs.(223)
Finance (expense)/income, net [(A)+(B)]  Rs.781   Rs.197   Rs.625   Rs.(24)

 

15. Share capital and share premium

 

The following table presents the changes in number of equity shares and amount of equity share capital for the six months ended September 30, 2018 and September 30, 2017:

 

   As of September 30, 2018   As of September 30, 2017 
   Number   Amount   Number   Amount 
Opening number of equity shares   165,910,907   Rs.830    165,741,713   Rs.829 
Issue of equity shares on exercise of options(1)   134,950    0    137,564    0 
Closing number of equity shares   166,045,857   Rs.830    165,879,277   Rs.829 
Treasury shares(2)   (25,000)  Rs.(64)   -    - 

 

(1)During the six months ended September 30, 2018 and 2017, equity shares were issued as a result of the exercise of vested options granted to employees pursuant to the Dr. Reddy’s Employees Stock Option Plan-2002 and Dr. Reddy’s Employees Stock Option Plan-2007. All of the options exercised had an exercise price of Rs.5, being equal to the par value of the underlying shares. Upon the exercise of such options, the amount of compensation cost (computed using the grant date fair value) previously recognized in the “share based payment reserve” was transferred to “share premium” in the unaudited condensed consolidated statements of changes in equity.

 

(2)Pursuant to the special resolution approved by the shareholders in the Annual General Meeting held on July 27, 2018, Dr. Reddy’s Employees ESOS Trust ( “ESOS Trust”) was incorporated to administer Dr. Reddy’s Employees Stock Option Scheme, 2018 with respect to the stock options to be granted against equity shares which the ESOS Trust may acquire under secondary acquisition. During the three months ended September 30, 2018, the ESOS Trust purchased 25,000 shares from secondary market for an aggregate consideration of Rs.64. Refer to Note 16 of these interim financial statements for further details on the Dr. Reddy’s Employees Stock Option Scheme, 2018.

 

 24 

 

 

DR. REDDY’S LABORATORIES LIMITED AND SUBSIDIARIES

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(in millions, except share and per share data and where otherwise stated)

 

16. Employee stock incentive plans

 

Dr. Reddy’s Employees Stock Option Scheme, 2018 (the “DRL 2018 Plan”)

 

The Company instituted the DRL 2018 Plan for all eligible employees pursuant to the special resolution approved by the shareholders at the Annual General Meeting held on July 27, 2018. The DRL 2018 Plan covers all employees and directors (excluding independent and promoter directors) of the parent company and its subsidiaries (collectively, “eligible employees”). Upon the exercise of options granted under the DRL 2018 Plan, the applicable equity shares may be issued directly by the Company to the eligible employee or may be transferred from the Dr. Reddy’s Employees ESOS Trust (the “ESOS Trust”) to the eligible employee. The ESOS Trust may acquire such equity shares through primary issuances by the Company and/or by way of secondary market acquisitions funded through loans from the Company. The Nomination, Governance and Compensation Committee of the Board of the parent company (the “Compensation Committee”) administers the DRL 2018 Plan and grants stock options to eligible employees, but may delegate functions and powers relating to the administration of the DRL 2018 Plan to the ESOS Trust. The Compensation Committee determines which eligible employees will receive 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 grant. The options issued under the DRL 2018 Plan vest in periods ranging between the end of one and five years, and generally have a maximum contractual term of five years.

 

The DRL 2018 Plan provides for option grants having an exercise price equal to the fair market value of the underlying equity shares on the date of grant as follows:

 

Particulars  Number of securities
to be acquired from
secondary market
   Number of securities
to be issued by the
Company
   Total 
Options reserved against equity shares   2,500,000    1,500,000    4,000,000 
Options reserved against ADRs   -    1,000,000    1,000,000 
Total   2,500,000    2,500,000    5,000,000 

 

Dr. Reddy’s Employees Stock Option Scheme, 2002 and Dr. Reddy’s Employees ADR Stock Option Plan, 2007

 

Pursuant to the special resolutions approved by the shareholders in the Annual General Meetings held on September 24, 2001 and on July 27, 2005, respectively, the Company instituted the Dr. Reddy’s Employees Stock Option Plan, 2002 (the “DRL 2002 Plan”), and the Dr. Reddy’s Employees ADR Stock Option Plan, 2007 (the “DRL 2007 Plan”), each of which also allows for grants of stock options to eligible employees.

 

Grants under Stock Incentive Plans

 

The terms and conditions of the grants made during the six months ended September 30, 2018 under the above plans and the DRL 2018 Plan were as follows:

 

Particulars  Number of
instruments
   Exercise price   Vesting period  Contractual life
DRL 2002 Plan   119,456   Rs.5.00   1 to 4 years  5 years
DRL 2007 Plan   70,730   Rs.5.00   1 to 4 years  5 years
DRL 2007 Plan   102,960   Rs.1,982.00   1 to 4 years  5 years
DRL 2007 Plan   46,200   Rs.2,607.00   1 to 4 years  5 years
DRL 2018 Plan   235,700   Rs.2,607.00   1 to 4 years  5 years

 

The above grants were made on May 21, 2018, July 26, 2018 and September 21, 2018.

 

The terms and conditions of the grants made during the six months ended September 30, 2017 under the above plans were as follows:

 

Particulars  Number of
instruments
   Exercise price   Vesting period  Contractual life
DRL 2002 Plan   158,112   Rs.5.00   1 to 4 years  5 years
DRL 2007 Plan   63,304   Rs.5.00   1 to 4 years  5 years

 

The above grants were made on May 11, 2017 and July 10, 2017.

 

 25 

 

 

DR. REDDY’S LABORATORIES LIMITED AND SUBSIDIARIES

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(in millions, except share and per share data and where otherwise stated)

 

16. Employee stock incentive plans (continued)

 

The fair value of services received in return for stock options granted to employees is measured by reference to the fair value of stock options granted. The fair value of stock options has been measured using the Black-Scholes-Merton valuation model at the date of the grant.

 

The weighted average inputs used in computing the fair value of such grants were as follows:

 

   September 21, 2018   July 26, 2018   May 21, 2018   July 10, 2017   May 11, 2017 
Expected volatility   33.98%   34.89%   32.97%   30.86%   30.08%
Exercise price  Rs.

5.00 /

Rs.2,607.00

   Rs.5.00   Rs.

5.00 / Rs.1,982.00

 

   Rs.5.00   Rs.5.00 
Option life   2.5 Years    2.5 Years    2.5 Years    2.5 Years    2.5 Years 
Risk-free interest rate   7.90%   7.47%   7.46%   6.48%   6.69%
Expected dividends   0.78%   0.94%   1.06%   0.77%   0.77%
Grant date share price  Rs.2,556.25   Rs.2,132.75   Rs.1,893.05   Rs.2,726.20   Rs.2,594.00 

 

Share-based payment expense

 

   For the six months ended
September 30,
   For the three months ended
September 30,
 
   2018   2017   2018   2017 
Equity settled share-based payment expense(1)  Rs.164   Rs.214   Rs.80   Rs.103 
Cash settled share-based payment expense(2)   38    7    18    (2)
   Rs.202   Rs.221   Rs.98   Rs.101 

 

(1)As of September 30, 2018, there was Rs.742 of total unrecognized compensation cost related to unvested stock options. This cost is expected to be recognized over a weighted-average period of 2.31 years.

 

(2)Certain of the Company’s employees are eligible to receive share based payment awards that are settled in cash. These awards would vest only upon satisfaction of certain service conditions which range from 1 to 4 years. These awards entitle the employees to a cash payment on the vesting date. The amount of the cash payment is determined based on the price of the Company’s ADSs at the time of vesting. As of September 30, 2018, there was Rs.139 of total unrecognized compensation cost related to unvested awards. This cost is expected to be recognized over a weighted-average period of 2.20 years. This scheme does not involve dealing in or subscribing to or purchasing securities of the Company, directly or indirectly.

 

17. Employee benefit plans

 

Gratuity benefits provided by the parent company

 

In accordance with applicable Indian laws, the Company has a defined benefit plan which provides for gratuity payments (the “Gratuity Plan”) and covers certain categories of employees in India. The Gratuity Plan provides a lump sum gratuity payment to eligible employees at retirement or termination of their employment. The amount of the payment is based on the respective employee’s last drawn salary and the years of employment with the Company. Effective September 1, 1999, the Company established the Dr. Reddy’s Laboratories Gratuity Fund (the “Gratuity Fund”) to fund the Gratuity Plan. Liabilities in respect of 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. Amounts contributed to the Gratuity Fund are invested in bonds issued by the Government of India, in debt securities and in equity securities of Indian companies. The liability recorded by the Company towards this obligation was Rs.32 and Rs.49 as at September 30, 2018 and March 31, 2018, respectively.

 

Compensated absences

 

The Company provides for accumulation of compensated absences by certain categories of its employees. These employees can carry forward a portion of the unutilized compensated absences and utilize them in future periods or receive cash in lieu thereof as per the Company’s policy. The Company records a liability for compensated absences in the period in which the employee renders the services that increases this entitlement. The total liability recorded by the Company towards this obligation was Rs.948 and Rs.1,093 as at September 30, 2018 and March 31, 2018, respectively.

 

 26 

 

 

DR. REDDY’S LABORATORIES LIMITED AND SUBSIDIARIES

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(in millions, except share and per share data and where otherwise stated)

 

18. Income taxes

 

Income tax expense is recognized based on the Company’s best estimate of the average annual income tax rate for the fiscal year applied to the pre-tax income of the interim period. The average annual income tax rate is determined for each taxing jurisdiction and applied individually to the interim period pre-tax income of each jurisdiction. The difference between the estimated average annual income tax rate and the enacted tax rate is accounted for by a number of factors, including the effect of differences between Indian and foreign tax rates, expenses that are not deductible for tax purposes, income exempted from income taxes, and effects of changes in tax laws and rates.

 

The Company’s consolidated weighted average tax rate for the six months ended September 30, 2018 and 2017 was 11.0% and 25.9%, respectively. Income tax expense was Rs.1,188 for the six months ended September 30, 2018, as compared to income tax expense of Rs.1,208 for the six months ended September 30, 2017.

 

The Company’s consolidated weighted average tax rate for the three months ended September 30, 2018 and 2017 was 12.8% and 26.5%, respectively. Income tax expense was Rs.742 for the three months ended September 30, 2018, as compared to income tax expense of Rs.1,027 for the three months ended September 30, 2017.

 

The effective rates of tax for the three and six months ended September 30, 2018 were lower primarily on account of the following:

 

a)tax effects arising from unrealized inter-company profits on inventory held by the Company in jurisdictions with different tax rates;

 

b)resolution of a certain tax matter in the Company’s favor resulting in a reversal of income tax expense pertaining to earlier years; and

 

c)changes in the Company’s jurisdictional mix of earnings (i.e., an increase in the proportion of the Company’s profits from lower tax jurisdictions and a decrease in the proportion of the Company’s profits from higher tax jurisdictions) for the three and six months ended September 30, 2018, as compared to the three and six months ended September 30, 2017.

 

Total tax benefits recognized directly in the equity were Rs.98 and Rs.355 for the three months and six months ended September 30, 2018, respectively (as compared to tax benefits of Rs.172 and Rs.522 for the three months and six months ended September 30, 2017, respectively). Such tax expenses and benefits were primarily due to tax effects on the changes in fair value of financial instruments and the foreign exchange gain/loss on cash flow hedges.

 

 27 

 

 

DR. REDDY’S LABORATORIES LIMITED AND SUBSIDIARIES

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(in millions, except share and per share data and where otherwise stated)

 

19. Related parties

 

The Company has entered into transactions with the following related parties:

 

Green Park Hotel and Resorts Limited for hotel services;
Green Park Hospitality Services Private Limited (“Green Park Hospitality”) for catering services;
Dr. Reddy’s Foundation towards contributions for social development;
Kunshan Rotam Reddy Pharmaceuticals Co. Limited (“Reddy Kunshan”) for sales of goods and for providing research and development services;
Pudami Educational Society towards contributions for social development;
Indus Projects Private Limited for engineering services relating to civil works;
CERG Advisory Private Limited for professional consulting services;
Dr. Reddy’s Institute of Life Sciences for research and development services; and
Stamlo Hotels Limited for hotel services.

 

These are enterprises over which key management personnel have control or significant influence. “Key management personnel” consists of the Company’s Directors and members of the Company’s Management Council.

 

The Company has also entered into cancellable operating lease transactions with key management personnel and close members of their families.

 

Further, the Company contributes to the Dr. Reddy’s Laboratories Gratuity Fund, which maintains the plan assets of the Company’s Gratuity Plan for the benefit of its employees.

 

The following is a summary of significant related party transactions:

 

   For the six months ended
September 30,
   For the three months ended
September 30,
 
   2018   2017   2018   2017 
Research and development services received  Rs.40   Rs.40   Rs.24   Rs.15 
Contributions towards social development   113    122    57    73 
Hotel expenses paid   16    23    8    8 
Catering expenses paid   106    74    60    63 
Lease rentals paid under cancellable operating leases   18    18    9    8 
Civil works   55    -    34    - 
Sales of goods   12    -    12    - 
Others   3    -    1    - 

 

The Company had the following amounts due from related parties as at the following dates:

 

   As at 
   September 30, 2018   March 31, 2018 
Key management personnel and close members of  their families  Rs.8   Rs.8 
Other related parties (Reddy Kunshan and Green Park Hospitality)   189    148 

 

The Company had the following amounts due to related parties as at the following dates:

 

   As at 
   September 30, 2018   March 31, 2018 
Due to related parties  Rs.4   Rs.14 

 

 28 

 

 

DR. REDDY’S LABORATORIES LIMITED AND SUBSIDIARIES

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(in millions, except share and per share data and where otherwise stated)

 

19. Related parties (continued)

 

The following table describes the components of compensation paid or payable to key management personnel for the services rendered during the applicable period:

 

   For the six months ended
September 30,
   For the three months ended
September 30,
 
   2018   2017   2018   2017 
Salaries and other benefits  Rs.291   Rs.222   Rs.167   Rs.114 
Contributions to defined contribution plans   18    15    9    8 
Commission to directors   118    165    59    82 
Share-based payments expense   49    47    18    22 
   Rs.476   Rs.449   Rs.253   Rs.226 

 

Some of the key management personnel of the Company are also covered under the Company’s Gratuity Plan along with the other employees of the Company. Proportionate amounts of gratuity accrued under the Company’s Gratuity Plan have not been separately computed or included in the above disclosure.

 

20. Nature of expense

 

The following table shows supplemental information related to certain “nature of expense” items for the three months and six months ended September 30, 2018 and 2017:

 

Depreciation and amortization  For the six months ended
September 30,
   For the three months
ended September 30,
 
   2018   2017   2018   2017 
Cost of revenues  Rs.3,336   Rs.3,289   Rs.1,652   Rs.1,676 
Selling, general and administrative expenses   2,010    1,841    1,056    950 
Research and development expenses   635    610    290    315 
   Rs.5,981   Rs.5,740   Rs.2,998   Rs.2,941 

 

Employee benefits  For the six months ended
September 30,
   For the three months
ended September 30,
 
   2018   2017   2018   2017 
Cost of revenues  Rs.5,621   Rs.5,202   Rs.2,882   Rs.2,566 
Selling, general and administrative expenses   8,957    8,336    4,573    4,111 
Research and development expenses   2,515    2,425    1,267    1,213 
   Rs.17,093   Rs.15,963   Rs.8,722   Rs.7,890 

 

 29 

 

 

DR. REDDY’S LABORATORIES LIMITED AND SUBSIDIARIES

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(in millions, except share and per share data and where otherwise stated)

 

21. Contingencies

 

The Company is involved in disputes, lawsuits, claims, governmental and/or regulatory inspections, inquiries, investigations and proceedings (collectively, “Legal Proceedings”), including patent and commercial matters that arise from time to time in the ordinary course of business. Most of the claims involve complex issues. Often, these issues are subject to uncertainties and therefore the probability of a loss, if any, being sustained and an estimate of the amount of any loss is difficult to ascertain. Consequently, for a majority of these claims, it is not possible to make a reasonable estimate of the expected financial effect, if any, that will result from ultimate resolution of the proceedings. This is due to a number of factors, including: the stage of the proceedings (in many cases trial dates have not been set) and the overall length and extent of pre-trial discovery; the entitlement of the parties to an action to appeal a decision; clarity as to theories of liability; damages and governing law; uncertainties in timing of litigation; and the possible need for further legal proceedings to establish the appropriate amount of damages, if any. In these cases, the Company discloses information with respect to the nature and facts of the case. The Company also believes that disclosure of the amount sought by plaintiffs, if that is known, would not be meaningful with respect to those legal proceedings.

 

Although there can be no assurance regarding the outcome of any of the Legal Proceedings referred to in this Note, the Company does not expect them to have a materially adverse effect on its financial position, as it believes that the likelihood of loss in excess of amounts accrued (if any) is not probable. However, if one or more of such Legal Proceedings were to result in judgments against the Company, such judgments could be material to its results of operations in a given period.

 

Note 39 to the Consolidated Financial Statements in the Company’s Annual Report on Form 20-F for the year ended March 31, 2018 contains a summary of significant Legal Proceedings. The following is a summary, as of the date of this Quarterly Report, of significant developments in those proceedings as well as any new significant proceedings commenced since the date such Annual Report on Form 20-F was filed.

 

Product and patent related matters

 

Launch of product “at-risk”

 

On June 14, 2018, the Company received final approval for Buprenorphine and Naloxone Sublingual Film, 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg, and 12 mg/3 mg, a therapeutic equivalent generic version of Suboxone® (buprenorphine and naloxone) sublingual film from the U.S. FDA.  The U.S. FDA approval came after the conclusion of litigation in the U.S. District Court for the District of Delaware, where the Delaware court concluded that patents covering Suboxone® sublingual film would not be infringed by the Company’s commercial launch of its generic sublingual film product.  In view of the favorable decision from the Delaware Court, the company launched its generic sublingual film product in the U.S. immediately following the U.S. FDA approval on June 14, 2018.  Following the launch, on June 15, 2018, Indivior PLC (“Indivior”) filed an emergency application for a temporary restraining order and preliminary injunction against the Company in the U.S. District Court for the District of New Jersey (the “New Jersey District Court”).  Indivior’s motion alleged that the Company’s generic sublingual film product infringed one of three newly-issued patents obtained by Indivior and asserted in the New Jersey Court.  Pending a hearing and decision on the injunction application, the New Jersey Court issued a temporary restraining order against the Company with respect to further sales, offer for sales, and imports of its generic sublingual film product in the United States.  Subsequently, on July 14, 2018, the New Jersey District Court granted a preliminary injunction in favor of Indivior.  The Company immediately appealed the decision and the U.S. Court of Appeals for the Federal Circuit (the “Court of Appeals”) agreed to expedite the appeal. The Court of Appeals heard oral argument on the Company’s appeal on October 4, 2018 and the Company is awaiting the judgment. 

 

The Company intends to vigorously defend its positions. Any liability that may arise on account of this complaint is unascertainable. Accordingly, no provision was made in the consolidated financial statements of the Company.

 

Litigation relating to Cardiovascular and Anti-diabetic formulations

 

As previously disclosed, the Company is involved in legal proceedings with India’s National Pharmaceutical Pricing Authority regarding allegations that the Company violated the maximum prices permissible for various formulations in the cardiovascular and anti-diabetic therapeutic areas under applicable price control regulations. The matter is adjourned to November 13, 2018 for hearing.

 

 30 

 

 

DR. REDDY’S LABORATORIES LIMITED AND SUBSIDIARIES

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(in millions, except share and per share data and where otherwise stated)

 

21. Contingencies (continued)

 

Product and patent related matters (continued)

 

Namenda litigation

 

As previously disclosed, in August 2015, Sergeants Benevolent Assoc. Health & Welfare Fund (“Sergeants”) filed suit against the Company and certain other defendants alleging that certain parties, including the Company, violated federal antitrust laws as a consequence of having settled patent litigation related to the Alzheimer’s drug Namenda® (memantine) tablets during a period from about 2009 until 2010. All defendants, including the Company, moved to dismiss the claims. On September 13, 2016, the Court denied the defendants’ motions; the motion pertaining to the claims against the Company was denied without prejudice. That same day, however, the Court stayed the Sergeants case pending resolution of similar claims in another case in which the Company is not a party (JM Smith Corp. v. Actavis PLC, now styled In re Namenda Direct Purchaser Antitrust Litigation, 15 Civ. 7488, S.D.N.Y.). The parties in the JM Smith Namenda Direct Purchaser case have served the Company with subpoenas, in response to which the Company produced the specific documents subpoenaed and provided testimony in a deposition. The Namenda Direct Purchaser case is now trial-ready. Discovery in that case is complete, and the Court has denied the motion for summary judgment filed by the defendants in that action, but no trial date has been set. By orders dated September 10, 2018 and October 10, 2018 the Court lifted the stay in the Sergeants litigation, and ordered that fact discovery be complete by December 19, 2018. Further events and deadlines have not yet been scheduled.

 

The Company believes that the likelihood of any liability that may arise on account of the Complaint is not probable. Accordingly, no provision has been made in these interim financial statements.

 

Child resistant packaging matter complaint under the False Claims Act (“FCA”)

 

As previously disclosed, during the year ended March 31, 2015, two former employees of the Company filed a complaint in the United States District Court for the Eastern District of Pennsylvania under the Federal False Claims Act, alleging that the Company had during prior years sold prescription drug products that failed to comply with child resistant blister packaging requirements (the “FCA Complaint”). During the three months ended March 31, 2018, the Company obtained dismissal of the FCA Complaint with prejudice. The plaintiffs subsequently filed a petition with the Court requesting that the Court reconsider its decision to dismiss the FCA Complaint with prejudice, and that request was denied.

 

In June 2018, the plaintiffs filed their Notice of Appeal to the Third Circuit Court of Appeals. During the three months ended September 2018, the plaintiffs and the DOJ settled and hence this appeal was dismissed. The plaintiffs then filed an application for recovery of attorneys' fees from the Company under the "alternative remedy doctrine." The Company filed counter against this and in response the plaintiffs withdrew their application.

 

The Company believes that the likelihood of any liability that may arise on account of the Complaint is not probable. Accordingly, no provision has been made in these interim financial statements.

 

Nexium litigation

 

As previously disclosed, two complaints, similar in nature to the Nexium litigation, were filed in the Court of Common Pleas in Philadelphia, Pennsylvania by plaintiffs who chose to opt out of the class action lawsuit. No dispositive motions were filed in these actions. Both matters were administratively closed by the Court on April 16, 2018.

 

Civil Litigation of Pricing/reimbursement matters

 

As previously disclosed, on November 17, 2016, certain class action complaints were filed against the Company and subsequently were consolidated into one amended complaint pending with the E.D.P.A Federal Court. These complaints allege that the Company and other named defendants have engaged in a conspiracy to fix prices and to allocate bids and customers in the sale of divalproex sodium extended-release tablets in the United States. In response to the consolidated new complaint, the Company filed a motion to dismiss on October 2017. The plaintiffs filed opposition to the motion to dismiss in December 2017 against which a reply was filed by the Company in January 2018. In October 2018, the Court denied the motion to dismiss on the grounds that the allegations pled leave open the possibility of conspiracy. Therefore, discovery will proceed to look into this possibility.

 

The Company believes that the asserted claims are without merit and intends to vigorously defend itself against the allegations. Any liability that may arise on account of this complaint is unascertainable. Accordingly, no provision was made in the consolidated financial statements of the Company.

 

 31 

 

 

DR. REDDY’S LABORATORIES LIMITED AND SUBSIDIARIES

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(in millions, except share and per share data and where otherwise stated)

 

21. Contingencies (continued)

 

Product and patent related matters (continued)

 

Multi-District Litigation (“MDL”)

 

As previously disclosed in Item 4 on page 43 to the Annual Report on Form 20-F for the year ended March 31, 2018, the Attorneys General for 45 States, plus the District of Columbia and the Commonwealth of Puerto Rico, filed a lawsuit asserting claims against a number of pharmaceutical companies, including the Company’s subsidiary, Dr. Reddy’s Laboratories, Inc., alleging conspiracies to fix prices and to allocate bids and customers, and such case was subsequently consolidated with certain private plaintiff class actions in a multi-district litigation in the United States District Court for the Eastern District of Pennsylvania, MDL 2724, In re Generic Pharmaceuticals Antitrust Pricing Litigation (the “MDL-2724”).

 

In June 2018, three additional class action complaints were filed in the MDL-2724 on behalf of classes of putative end payer plaintiffs, indirect reseller plaintiffs, and direct purchaser plaintiffs. All three complaints allege conspiracy in restraint of trade in violation of Sections 1 and 3 of the Sherman Act, and violations of 31 State antitrust statutes, Consumer Protection statutes and claims of Unjust Enrichment seeking injunctive relief, recovery of treble damages, punitive damages, attorney's fees and costs.  The complaints allege an “overarching conspiracy” among the named defendants involving fifteen drugs and, with slight variations, name approximately 25 generic pharmaceutical manufacturers including Dr. Reddy’s Laboratories, Inc. The drug-specific allegations against Dr. Reddy’s Laboratories, Inc. involve two of the fifteen drugs, meprobamate and zoledronic acid. However, plaintiffs also allege that Dr. Reddy’s Laboratories, Inc. (as well as all other manufacturers named) were part of a larger conspiracy as to all of the drugs named in the complaints. 

 

On September 25, 2018, Marion Diagnostic Center, LLC and Marion Healthcare, LLC filed a complaint in the MDL-2724, on behalf of themselves and a class of all direct purchasers from distributors, against Dr. Reddy’s Laboratories, Inc. and 22 other defendants, including a major distributor of pharmaceutical products. Such complaint alleges an “overarching conspiracy” for price fixing and to rig bids and allocate customers with respect to 16 drugs. Dr. Reddy’s Laboratories, Inc. was specifically named with respect to two drugs: meprobamate and zoledronic acid. Such complaint also alleges violations of Section 1 of the Sherman Act, 15 U.S.C. §1, and violations of 24 State antitrust statutes, Consumer Protection statutes and claims of Unjust Enrichment, seeking injunctive relief, recovery of treble damages, punitive damages, attorney's fees and costs.

 

Similarly, The Kroger Co., Albertsons Companies, LLC, and the H.E. Butt Grocery Company, L.P. filed claims in the MDL-2724 against Dr. Reddy’s Laboratories, Inc., and 33 other defendants alleging an “overarching” price fixing conspiracy and to rig bids and allocate customers with respect to 30 generic drugs. Dr. Reddy’s Laboratories, Inc. was specifically named as to four drugs: divalproex ER, meprobamate, pravastatin and zoledronic acid. Additionally, similar complaints were filed by Humana, Inc. against 34 defendants (including Dr. Reddy’s Laboratories, Inc.), involving a total of 16 generic drugs, and naming Dr. Reddy’s Laboratories, Inc. specifically with respect to two drugs: divalproex ER and pravastatin sodium tablets. The complaints allege violations of Section 1 of the Sherman Act, 15 U.S.C. §1, seeking injunctive relief, recovery of treble damages, punitive damages, attorney's fees and costs.

 

The Company believes that the asserted claims are without merit and intends to vigorously defend itself against the allegations. Any liability that may arise on account of this complaint is unascertainable. Accordingly, no provision was made in the consolidated financial statements of the Company.

 

Securities Class Action Litigation

 

As previously disclosed, in August 2017 a securities class action lawsuit complaint was filed in the United States District Court for the District of New Jersey, alleging that the Company made false or misleading statements or omissions in its public filings, in violation of U.S. federal securities laws, and that the Company’s share price dropped and its investors were affected and, on May 9, 2018, the Company and other defendants filed a motion to dismiss the complaint.

 

On June 25, 2018, the plaintiffs filed an opposition to the motion to dismiss and, on July 25, 2018, a further reply in support of the motion to dismiss was filed by the Company. In August 2018, oral argument on the motion to dismiss was heard by the court and the parties are awaiting the decision.

 

The Company believes that the asserted claims are without merit and intends to vigorously defend itself against the allegations. Any liability that may arise on account of this complaint is unascertainable. Accordingly, no provision was made in the consolidated financial statements of the Company.

 

 32 

 

 

DR. REDDY’S LABORATORIES LIMITED AND SUBSIDIARIES

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(in millions, except share and per share data and where otherwise stated)

 

21. Contingencies (continued)

 

Glenmark Litigation

 

In November 2017, the Company received a letter from Glenmark Farmaceutica Ltda and Glenmark Pharmaceuticals Limited (collectively “Glenmark”), for invocation of arbitration under a distribution agreement and a deed of assignment relating to a product between the Company and Glenmark. The arbitration was invoked alleging that the non-supply of the product by the Company severely affected the value of the Intellectual Property and goodwill and therefore Glenmark claims to recover the loss along with interest and penalties from the Company.

 

Glenmark approached the Supreme Court of India relating to the appointment of an arbitrator and in March 2018, an arbitrator was appointed by the Supreme Court. In July 2018, Glenmark filed a claim statement against the Company and in September 2018, the Company filed a reply against the claim along with a counter claim.

 

The Company believes that the asserted claims are without merit and intends to vigorously defend itself against the allegations. Any liability that may arise on account of this complaint is unascertainable. No provision was made in the interim financial statements of the Company.

 

Environmental matters

 

Land pollution

 

As previously disclosed, since 1989 the Company has been involved in a series of legal proceedings relating to allegations that the Company, along with various other co-defendants, effected discharges of pollution that damaged certain farms and other lands in the Patancheru and Bollarum areas of Medak district of Andhra Pradesh, India. A court had ordered the defendants to compensate certain farmers at a specified rate, resulting in a total compensation of Rs.3 paid by the Company. The appeal of the ruling was ultimately transferred to the National Green Tribunal (“NGT”), Chennai, which disposed of this matter in a judgment dated October 24, 2017.

 

The Bulk Drug Manufacturers Association of India (“BDMAI”), in which the Company is a member, subsequently filed a review petition against the judgment on various aspects. The NGT, Delhi, in a judgment dated November 16, 2017 in another case in which the Company is not a party, stated that the moratorium on expansion of industries imposed in the Patancheru and Bollaram areas shall continue until the Ministry of Environment, Forest and Climate Change passes an order keeping in view the needs of the environment and public health. The Company filed an appeal challenging this judgment.

 

The High Court of Hyderabad heard the Company’s appeal challenging this judgment in July 2018 and directed the respondents to file their response within a period of four weeks. During the three months ended September 30, 2018, the respondents filed counter affidavits and the matter has now been adjourned for final hearing.

 

The Company believes that any additional liability that might arise in this regard is not material to the consolidated financial statements. Accordingly, no provision relating to these claims has been made in the interim financial statements.

 

Water pollution and air pollution

 

As previously disclosed, during the year ended March 31, 2012, the Andhra Pradesh Pollution Control Board alleged that the Company and various other defendants violated the Indian Water Pollution Act and the Indian Air Pollution Act, and issued orders limiting activities at certain of the Company’s manufacturing facilities in Hyderabad, India. The Company appealed these orders to the Andhra Pradesh Pollution Appellate Board (the “APP Appellate Board”), which recommended to the Andhra Pradesh Government to allow expansion of units fully equipped with Zero-Liquid Discharge (“ZLD”) facilities and otherwise found no fault with the Company (on certain conditions). The APP Appellate Board’s decision was challenged by one of the petitioners in the National Green Tribunal.

 

The challenge to the APP Appellate Board’s decision is transferred to the NGT, Delhi for a final hearing, the date for which has not yet been notified. No provision relating to these claims has been made in the interim financial statements.

 

Others

 

Additionally, the Company is involved in other disputes, lawsuits, claims, governmental and/or regulatory inspections, inquiries, investigations and proceedings, including patent and commercial matters that arise from time to time in the ordinary course of business. Except as discussed above, the Company does not believe that there are any such contingent liabilities that are expected to have any material adverse effect on its financial statements.

 

 33 

 

 

DR. REDDY’S LABORATORIES LIMITED AND SUBSIDIARIES

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(in millions, except share and per share data and where otherwise stated)

 

22. Investment in Curis Inc.

 

In May 2018, Curis Inc. completed a 1-for-5 reverse stock split of its common stock. After giving effect to such stock split, the total number of equity shares held by the Company is 5.47 million.

 

Upon transition to IFRS 9, the Company applied the irrevocable FVTOCI option on the equity shares held by the Company.

 

As of September 30, 2018, a loss of Rs.1,993 arising from changes in the fair value of such shares of common stock was recorded in other comprehensive income.

 

 34 

 

  

DR. REDDY’S LABORATORIES LIMITED AND SUBSIDIARIES

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(in millions, except share and per share data and where otherwise stated)

 

23. Receipt of warning letter from the U.S. FDA

 

The Company received a warning letter dated November 5, 2015 from the U.S. FDA relating to current Good Manufacturing Practices (“cGMPs”) deviations at its active pharmaceutical ingredient (“API”) manufacturing facilities at Srikakulam, Andhra Pradesh and Miryalaguda, Telangana, as well as violations at its oncology formulation manufacturing facility at Duvvada, Visakhapatnam, Andhra Pradesh. The contents of the warning letter emanated from Form 483 observations that followed inspections of these sites by the U.S. FDA in November 2014, January 2015 and February-March 2015.

 

The warning letter did not restrict production or shipment of the Company’s products from these facilities. However, unless and until the Company is able to correct outstanding issues to the U.S. FDA's satisfaction, the U.S. FDA may withhold approval of new products and new drug applications of the Company, refuse admission of products manufactured at the facilities noted in the warning letter into the United States, and/or take additional regulatory or legal action against the Company. Any such further action could have a material and negative impact on the Company’s ongoing business and operations. During the years ended March 31, 2016, 2017 and 2018, the U.S. FDA withheld approval of new products from these facilities pending resolution of the issues identified in the warning letter. To minimize the business impact, the Company transferred certain key products to alternate manufacturing facilities.

 

Subsequent to the issuance of the warning letter, the Company promptly instituted corrective actions and preventive actions and submitted a comprehensive response to the warning letter to the U.S. FDA, followed by periodic written updates and in-person meetings with the U.S. FDA. The U.S. FDA completed the re-inspection of the aforementioned manufacturing facilities in the months of February, March and April 2017. During the re-inspections, the U.S. FDA issued three observations with respect to the API manufacturing facility at Miryalaguda, two observations with respect to the API manufacturing facility at Srikakulam and thirteen observations with respect to the Company’s oncology formulation manufacturing facility at Duvvada. The Company responded to these observations identified by the U.S. FDA and believes that it can resolve them in a timely manner.

 

In June 2017, the U.S. FDA issued an Establishment Inspection Report (“EIR”) which indicated that the inspection of the Company’s API manufacturing facility at Miryalaguda is successfully closed. With regard to the Company’s oncology manufacturing facility at Duvvada and its API manufacturing facility at Srikakulam, the Company received EIRs from the U.S. FDA in November 2017 and February 2018, respectively, which indicated that the inspection status of these facilities remains unchanged. In June 2018, the Company requested the U.S. FDA to schedule a re-inspection of the oncology formulation manufacturing facility at Duvvada. In October 2018, the re-inspection was completed and the U.S.FDA issued Form 483 with eight observations. The Company is in the process of addressing these observations. With respect to the API manufacturing facility at Srikakulam, the Company was asked to carry out certain detailed investigations and analyses. In response, the Company submitted the results of the investigations and analyses in October 2018. As part of the review of the response by the U.S. FDA, certain additional follow on queries have been received by the Company. The Company is in the process of responding to these queries.

 

Inspection of other facilities:

 

In May and June 2017, inspection of the Company’s Formulations Srikakulam Plant (SEZ) Unit II and I, India, was completed by the U.S. FDA with zero and one observations, respectively, and the U.S. FDA issued EIRs in September 2017 for both Units II and I, indicating the closure of the audit for these facilities.

 

The inspection of the Company’s Custom Pharmaceutical Services facility in Hyderabad, India was completed by the U.S. FDA on September 21, 2017 with zero observations, and the U.S. FDA issued an EIR in December 2017 indicating the closure of audit for this facility.

 

In April 2017, inspection of the Company’s formulations manufacturing facility at Bachupally, Hyderabad was completed by the U.S. FDA and the Company was issued a Form 483 with 11 observations. In December 2017, the U.S. FDA issued an EIR which indicates the closure of the audit for this facility.

 

In July 2017, inspection of the Company’s API facility in Cuernavaca, Mexico was completed by the U.S. FDA with zero observations, and the U.S. FDA issued an EIR in April 2018 indicating the closure of the audit for this facility.

 

 35 

 

 

DR. REDDY’S LABORATORIES LIMITED AND SUBSIDIARIES

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(in millions, except share and per share data and where otherwise stated)

 

23. Receipt of warning letter from the U.S. FDA (continued)

 

The inspection of the Company’s API facility in Mirfield, United Kingdom was completed by the U.S. FDA on September 15, 2017, and the Company was issued a Form 483 with three observations. The Company responded to the observations identified by the U.S. FDA, and the U.S. FDA issued an EIR on April 24, 2018, which indicates the closure of the audit for this facility.

 

In March 2018, inspection of the Company’s API Hyderabad Plant 1 and API Hyderabad Plant 3 manufacturing facilities was completed by the U.S. FDA with four and five observations, respectively. The observations at API Hyderabad Plant 3 were related to procedures and facility maintenance. The Company responded to the observations relating to both facilities and, in June 2018, received an EIR indicating the closure of the audit for both facilities.

 

In June 2018, an inspection of the Company’s API Srikakulam Plant (SEZ) was completed by the U.S. FDA with zero observations, and the U.S. FDA issued an EIR in August 2018 indicating the closure of the audit for this facility.

 

24. Inspection by the regulatory authority of Bavaria, Germany

 

In August 2017, the Company’s German subsidiary betapharm Arzneimittel GmbH received a letter from a regulatory authority of Bavaria, Germany (the Regierung von Oberbayern, which is the Central Authority for Supervision of Medicinal Products in Bavaria of the Upper Bavarian government) (the “Regulator”), that the GMP compliance certificate for the Company’s formulations manufacturing facility at Bachupally, Hyderabad was not renewed as the result of GMP compliance deviations identified in an inspection. Consequently, this manufacturing facility was not permitted to export products to the European Union (the “EU”) until satisfactory resolution of the issues identified in the inspection and renewal of the facility’s GMP compliance certificate. The manufacturing facility was re-inspected in January 2018 and the status of non-compliance was withdrawn. The facility since then is permitted to dispatch approved products to the EU.

 

Furthermore, on September 7, 2017, the Regulator concluded an inspection of the Company’s formulations manufacturing facility at Duvvada, Visakhapatnam, with zero critical and six major observations. The Company submitted a Corrective and Preventive Action Plan (“CAPA”) to the Regulator in this regard which was accepted by the Regulator. Consequently, the Regulator permitted the Company to start production from this facility for the EU market. The German Regulator intends to re-inspect this facility by the end of calendar year 2018.

 

25. Disposal group

 

In October 2018, the Company entered into a definitive agreement for the sale of its manufacturing facility, API Hyderabad Plant 4, located in Jeedimetla, Hyderabad and forming part of its PSAI segment to Therapiva Private Limited, Hyderabad. This divestiture was done by way of slump sale including all related property, plant and equipment, current assets, current liabilities, and transfer of employees.

 

The carrying value of all the assets and liabilities forming part of this divestiture is disclosed as a disposal group held for sale in the unaudited condensed consolidated interim statement of financial position.

 

Tabulated below are the carrying values of the assets and liabilities forming part of the disposal group held for sale as on September 30, 2018:

 

   Amount 
Property, plant and equipment   Rs.426 
Inventories   387 
Other assets   16 
Assets of disposal group held for sale (A)  Rs.829 
Trade and other payables  Rs.56 
Other liabilities   21 
Liabilities of disposal group held for sale (B)  Rs.77 
Net assets of disposal group held for sale [(A)+(B)]  Rs.752 

 

 36 

 

 

DR. REDDY’S LABORATORIES LIMITED AND SUBSIDIARIES

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(in millions, except share and per share data and where otherwise stated)

 

26. Revenues

 

   For the six months ended
September 30,
   For the three months
ended September 30,
 
   2018   2017   2018   2017 
Sales  Rs.73,374   Rs.67,394   Rs.36,867   Rs.34,904 
Service income   1,000    782    561    316 
License fees   811    443    550    240 
   Rs.75,185   Rs.68,619   Rs.37,978   Rs.35,460 
Excise duty included in revenues  Rs.-   Rs.173   Rs.-   Rs.- 

 

Refund liability amounting to Rs.3,351 and Rs.3,210 as of September 30, 2018 and March 31, 2018, respectively, has been included in provisions forming part of current liabilities.

 

27. Subsequent events

 

None.

 

 37 

 

  

ITEM 2. OPERATING AND FINANCIAL REVIEW, TREND INFORMATION

 

The following discussion and analysis should be read in conjunction with the audited consolidated financial statements, the related cash flow statement, notes and the Operating and Financial Review and Prospects included in our Annual Report on Form 20-F for the fiscal year ended March 31, 2018, and the unaudited condensed consolidated interim financial statements included in our report on Form 6-K for the three months ended June 30, 2018, all of which are on file with the SEC, and the unaudited condensed consolidated interim financial statements contained in this report on Form 6-K.

 

This discussion contains forward-looking statements that involve risks and uncertainties. When used in this discussion, the words “anticipate”, “believe”, “estimate”, “intend”, “will” and “expect” and other similar expressions as they relate to us or our business are intended to identify such forward-looking statements. We undertake no obligation to publicly update or revise the forward-looking statements, whether as a result of new information, future events, or otherwise. Actual results, performances or achievements could differ materially from those expressed or implied in such forward-looking statements. Factors that could cause or contribute to such differences include those described under the heading “Risk Factors” in our Form 20-F. Readers are cautioned not to place reliance on these forward-looking statements that speak only as of their dates.

 

Section A:

 

Three months ended September 30, 2018 compared to the three months ended September 30, 2017

 

The following table sets forth, for the periods indicated, financial data along with respective percentages to total revenues and the increase (or decrease) by item as a percentage of the amount over the comparable period in the previous year.

 

   For the three months ended September 30, 
   2018   2017     
   Rs. in
millions
   % of
Revenues
   Rs. in
millions
   % of
Revenues
   Increase/
(Decrease)
 
Revenues  Rs.37,978    100.0%  Rs.35,460    100.0%   7%
Gross profit   20,897    55.0%   18,901    53.3%   11%
Selling, general and administrative expenses   12,372    32.6%   11,032    31.1%   12%
Research and development expenses   4,120    10.8%   4,175    11.8%   (1)%
Other income, net   (641)   (1.7)%   (114)   (0.3)%   462%
Results from operating activities   5,046    13.3%   3,808    10.7%   33%
Finance (expense)/income, net   625    1.6%   (24)   (0.1)%   (2704)%
Share of profit of equity accounted investees, net of  tax   109    0.3%   92    0.3%   18%
Profit before tax   5,780    15.2%   3,876    10.9%   49%
Tax expense   742    2.0%   1,027    2.9%   (28)%
Profit for the period  Rs.5,038    13.3%  Rs.2,849    8.0%   77%

 

Revenues

 

Our overall consolidated revenues were Rs.37,978 million for the three months ended September 30, 2018, an increase of 7% as compared to Rs.35,460 million for the three months ended September 30, 2017.

 

The following table sets forth, for the periods indicated, our consolidated revenues by segment:

 

   For the three months ended September 30, 
   2018   2017     
   Rs. in
millions
   Revenues %
of Total
   Rs. in
millions
   Revenues %
of Total
   Increase/
(Decrease)
 
Global Generics  Rs.30,536    80%  Rs.28,618    81%   7%
PSAI   6,029    16%   5,654    16%   7%
Proprietary Products   776    2%   748    2%   4%
Others   637    2%   440    1%   45%
Total  Rs.37,978    100%  Rs.35,460    100%   7%

 

 38 

 

 

Segment Analysis

 

Global Generics

 

Revenues from our Global Generics segment were Rs.30,536 million for the three months ended September 30, 2018, an increase of 7% as compared to Rs.28,618 million for the three months ended September 30, 2017.

 

After taking into account the impact of exchange rate fluctuations of the Indian rupee against multiple currencies in the markets in which we operate, the foregoing increase in revenues of this segment was attributable to the following factors:

 

·an increase of approximately 9% resulting from the introduction of new products during the period;
·an increase of approximately 5% resulting from an increase in the sales volume of existing products in this segment; and

·the foregoing was partially offset by a decrease of approximately 7% resulting from the net impact of changes in sales prices of the products in this segment.

 

North America (the United States and Canada): Our Global Generics segment’s revenues from North America (the United States and Canada) were Rs.14,265 million for the three months ended September 30, 2018, a decrease of 0.4% as compared to the three months ended September 30, 2017. In U.S. dollar absolute currency terms (i.e., U.S. dollars without taking into account the effect of currency exchange rates), such revenues decreased by 6% in the three months ended September 30, 2018 as compared to the three months ended September 30, 2017.

 

This decrease in revenues was largely attributable to the following:

 

·price erosion in certain of our existing products; and

 

·the foregoing was partially offset by revenues from new products launched between October 1, 2017 and September 30, 2018, such as sevelamer carbonate tablets, levetiracetam bags and palonosetron injection.

 

During the three months ended September 30, 2018, we launched four new products in North America (the United States and Canada). These new products are OTC esomeprazole tablets, neostigmine injection, hydroxychloroquine tablets and Nitro-Dur® patch.

 

During the three months ended September 30, 2018, we made three new ANDA filings to the U.S.FDA. As of September 30, 2018, we had 113 filings pending approval at the U.S. FDA, which includes three NDA filings under section 505(b) (2) and 110 ANDA filings. Out of these 110 ANDA filings, 63 are Paragraph IV filings and we believe we are the first to file with respect to 32 of these filings.

 

India: Our Global Generics segment’s revenues from India for the three months ended September 30, 2018 were Rs.6,864 million, an increase of 8% as compared to the three months ended September 30, 2017. This increase was primarily attributable to an increase in sales price of our existing products and new products we launched between October 1, 2017 and September 30, 2018.

 

According to IQVIA in its Moving Quarterly Total report for the three months ended September 30, 2018, our secondary sales in India increased by 11.8% during such period, as compared to the India pharmaceutical market’s growth of 13.3% during such period. During the three months ended September 30, 2018, we launched six brands in India.

 

Emerging Markets: Our Global Generics segment’s revenues from “Emerging Markets” (which is comprised of Russia, other countries of the former Soviet Union, Romania and certain other countries from our “Rest of the World” markets, primarily, China, South Africa, and Brazil) for the three months ended September 30, 2018 were Rs.7,492 million, an increase of 36% as compared to the three months ended September 30, 2017.

 

Russia: Our Global Generics segment’s revenues from Russia for the three months ended September 30, 2018 were Rs.3,793 million, an increase of 18% as compared to the three months ended September 30, 2017. In Russian rouble absolute currency terms (i.e., Russian roubles without taking into account the effect of currency exchange rates), such revenues increased by 21% for the three months ended September 30, 2018 as compared to the three months ended September 30, 2017. The increase in revenues was primarily on account of an increase in the sales prices of our existing products and new products we launched between October 1, 2017 and September 30, 2018. Our OTC division’s revenues from Russia for the three months ended September 30, 2018 were 41% of our total revenues from Russia.

 

 39 

 

 

According to IQVIA, as per its report for the two months ended August 31, 2018, our sales value (in Russian roubles) growth and volume growth from Russia, as compared to the Russian pharmaceutical market sales value (in Russian roubles) growth and volume growth for the two months ended August 31, 2018, was as follows:

 

   For the two months ended August 31, 2018 
   Dr. Reddy's Laboratories   Russian pharmaceutical
market
 
   Sales value   Volume   Sales value   Volume 
Prescription (Rx)   4.05%   (3.11)%   9.01%   2.19%
Over-the-counter (OTC)   5.81%   (2.02)%   6.80%   (1.96)%
Total (Rx + OTC)   4.80%   (2.76)%   7.90%   (0.68)%

 

Other countries of the former Soviet Union and Romania: Our Global Generics segment’s revenues from other countries of the former Soviet Union and Romania were Rs.1,441 million for the three months ended September 30, 2018, an increase of 56% as compared to the three months ended September 30, 2017. This increase was largely attributable to the increase in sales volumes of our existing major brands coupled with new products launched between October 1, 2017 and September 30, 2018.

 

“Rest of the World” Markets: We refer to all markets of this segment other than North America (the United States and Canada), Europe, Russia and other countries of the former Soviet Union, Romania and India as our “Rest of the World” markets. Our Global Generics segment’s revenues from our “Rest of the World” markets were Rs.2,258 million for the three months ended September 30, 2018, an increase of 65% as compared to the three months ended September 30, 2017. This increase was largely attributable to an increase in the sales volumes of our existing products, as well as new products launched between October 1, 2017 and September 30, 2018. Growth was further driven by increase in sales contributions from new markets such as Brazil and China.

 

Europe: Our Global Generics segment’s revenues from Europe are derived from Germany, the United Kingdom, Italy, France, Spain and our out-licensing business across Europe. Such revenues were Rs.1,915 million for the three months ended September 30, 2018, a decrease of 21% as compared to the three months ended September 30, 2017. This decrease was primarily on account of a decrease in prices of our existing products, and the foregoing was partially offset by revenues from new products launched between October 1, 2017 and September 30, 2018.

 

Pharmaceutical Services and Active Ingredients (“PSAI”)

 

Our PSAI segment’s revenues for the three months ended September 30, 2018 were Rs.6,029 million, an increase of 7% as compared to the three months ended September 30, 2017. After taking into account the impact of exchange rate fluctuations of the Indian rupee against multiple currencies in the markets in which we operate, this increase was largely attributable to:

 

·an increase in sales of active pharmaceutical ingredients for the three months ended September 30, 2018, which increased our PSAI segment’s revenues by approximately 4%; and

 

·an increase in sales of our pharmaceutical development services, which increased our PSAI segment’s revenues by approximately 3%.

 

Proprietary Products

 

Revenues from our Proprietary Products segment were Rs.776 million for the three months ended September 30, 2018, an increase of 4% as compared to Rs.748 million for the three months ended September 30, 2017.

 

 40 

 

 

Gross Profit

 

Our total gross profit was Rs.20,897 million for the three months ended September 30, 2018, representing 55.0% of our revenues for that period, as compared to Rs.18,901 million for the three months ended September 30, 2017, representing 53.3% of our revenues for that period.

 

The following table sets forth, for the period indicated, our gross profits by segment:

 

   For the three months ended September 30, 
   2018   2017 
   (Rs. in millions) 
   Gross Profit   % of Segment
Revenue
   Gross Profit   % of Segment
Revenue
 
Global Generics  Rs.18,111    59.3%  Rs.16,936    59.2%
PSAI   1,697    28.1%   1,107    19.6%
Proprietary Products   653    84.1%   633    84.5%
Others   436    68.4%   225    51.1%
Total  Rs.20,897    55.0%  Rs.18,901    53.3%

 

After taking into account the impact of the exchange rate fluctuations of the Indian rupee against multiple currencies in the markets in which we operate, the gross profits from our Global Generics segment increased to 59.3% for the three months ended September 30, 2018 from 59.2% for the three months ended September 30, 2017. This increase was primarily from introduction of new products with higher margins offset by price erosion in some of our key existing products during the intervening period.

 

The gross profits from our PSAI segment increased to 28.1% for the three months ended September 30, 2018, from 19.6% for the three months ended September 30, 2017. This increase was primarily due to higher realizations in some of our key molecules coupled with changes in our existing product mix (i.e., an increase in the proportion of sales of higher gross margin products and a decrease in the proportion of sales of lower gross margin products).

 

Selling, general and administrative expenses

 

Our selling, general and administrative expenses were Rs.12,372 million for the three months ended September 30, 2018, an increase of 12% as compared to Rs.11,032 million for the three months ended September 30, 2017. After taking into account the impact of exchange rate fluctuations of the Indian rupee against multiple currencies in the markets in which we operate, this increase was largely attributable to the following:

 

·an increase in personnel costs, primarily on account of annual raises which increased our selling, general and administrative expenses by approximately 4%;

 

·an increase in sales and marketing expenses, which increased our selling, general and administrative expenses by approximately 3%;

 

·an increase in freight outward expenses, which increased our selling, general and administrative expenses by approximately 3%; and

 

·an increase in other costs, which increased our selling, general and administrative expenses by approximately 1%.

 

As a proportion of our total revenues, our selling, general and administrative expenses increased to 32.6% for the three months ended September 30, 2018 from 31.1% for the three months ended September 30, 2017.

 

Research and development expenses

 

Our research and development expenses were Rs.4,120 million for the three months ended September 30, 2018, a decrease of 1% as compared to Rs.4,175 million for the three months ended September 30, 2017. The decrease was primarily on account of timing variations in development related activities. Our focus continues on building our pipeline of complex generics, biosimilars and differentiated products.

 

As a proportion of our total revenues, our research and development expenses was at 10.8% for the three months ended September 30, 2018, as compared to 11.8% for the three months ended September 30, 2017.

 

 41 

 

 

Other (income)/expense, net

 

·Our net other income was Rs.641 million for the three months ended September 30, 2018, as compared to net other income of Rs.114 million for the three months ended September 30, 2017. Our net other income for the three months ended September 30, 2018 primarily includes Rs.464 million on account of our sale of rights relating to an intangible asset forming part of our Proprietary Products Segment and our sale of all of the membership interests in Dr. Reddy’s Laboratories Tennessee, LLC.

 

Finance income/(expense), net

 

Our net finance income was Rs.625 million for the three months ended September 30, 2018, as compared to net finance expense of Rs.24 million for the three months ended September 30, 2017. The increase in net finance income was due to the following:

 

·profit on sale of investments, and unrealized gains on investments recorded at fair value through profit and loss, of Rs.113 million for the three months ended September 30, 2018, as compared to profit on sale of investments of Rs.88 million for the three months ended September 30, 2017;

 

·net interest income of Rs.19 million for the three months ended September 30, 2018, as compared to net interest expense of Rs.159 million for the three months ended September 30, 2017; and

 

·net foreign exchange gain of Rs.493 million for the three months ended September 30, 2018, as compared to net foreign exchange gain of Rs.47 million for the three months ended September 30, 2017.

 

Profit before tax

 

As a result of the above, our profit before tax was Rs.5,780 million for the three months ended September 30, 2018, as compared to Rs.3,876 million for the three months ended September 30, 2017.

 

Tax expense

 

Our consolidated weighted average tax rate was 12.8% for the three months ended September 30, 2018, as compared to 26.5% for the three months ended September 30, 2017. The effective rate for the three months ended September 30, 2018 was lower as compared to the three months ended September 30, 2017, primarily on account of tax effects arising from unrealized inter-company profits on inventory held in jurisdictions with different tax rates, resolution of a certain tax matter in the our favor resulting in a reversal of income tax expense pertaining to earlier years, and favourable changes in our jurisdictional mix of earnings.

 

Our tax expense was Rs.742 million for the three months ended September 30, 2018, as compared to Rs.1,027 million for the three months ended September 30, 2017.

 

Profit for the period

 

As a result of the above, our net profit was Rs.5,038 million for the three months ended September 30, 2018, representing 13.3% of our total revenues for such period, as compared to Rs.2,849 million for the three months ended September 30, 2017, representing 8.0% of our total revenues for such period.

 

 42 

 

  

Section B:

 

Six months ended September 30, 2018 compared to the six months ended September 30, 2017

 

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 comparable period in the previous year.

 

   For the six months ended September 30, 
   2018   2017     
   Rs. in
millions
   % of
Revenues
   Rs. in
millions
   % of
Revenues
   Increase/
(Decrease)
 
Revenues  Rs.75,185    100.0%  Rs.68,619    100.0%   10%
Gross profit   41,625    55.4%   35,998    52.5%   16%
Selling, general and administrative expenses   24,478    32.6%   22,795    33.2%   7%
Research and development expenses   8,277    11.0%   9,250    13.5%   (11)%
Other income, net   (944)   (1.3)%   (308)   (0.4)%   206%
Results from operating activities   9,814    13.1%   4,261    6.2%   130%
Finance income, net   781    1.0%   197    0.3%   296%
Share of profit of equity accounted investees, net of  tax   192    0.3%   190    0.3%   1%
Profit before tax   10,787    14.3%   4,648    6.8%   132%
Tax expense   1,188    1.6%   1,208    1.8%   (2)%
Profit for the period  Rs.9,599    12.8%  Rs.3,440    5.0%   179%

 

Revenues

 

Our overall consolidated revenues were Rs.75,185 million for the six months ended September 30, 2018, an increase of 10% as compared to Rs.68,619 million for the six months ended September 30, 2017.

 

The following table sets forth, for the periods indicated, our consolidated revenues by segment:

 

   For the six months ended September 30, 
   2018   2017     
   Rs. in
millions
   Revenues %
of Total
   Rs. in
millions
   Revenues %
of Total
   Increase/
(Decrease)
 
Global Generics  Rs.61,172    81%  Rs.56,073    82%   9%
PSAI   11,438    15%   10,305    15%   11%
Proprietary Products   1,502    2%   1,260    2%   19%
Others   1,073    2%   981    1%   9%
Total  Rs.75,185    100%  Rs.68,619    100%   10%

 

 43 

 

 

Segment Analysis

 

Global Generics

 

Revenues from our Global Generics segment were Rs.61,172 million for the six months ended September 30, 2018, an increase of 9% as compared to Rs.56,073 million for the six months ended September 30, 2017.

 

After taking into account the impact of exchange rate fluctuations of the Indian rupee against multiple currencies in the markets in which we operate, the foregoing increase in revenues of this segment was attributable to the following factors:

 

·an increase of approximately 11% resulting from the introduction of new products during the intervening period;
·an increase of approximately 8% resulting from a net increase in the sales volume of existing products in this segment; and
·a decrease of approximately 10% resulting from the net impact of changes in sales prices of the products in this segment.

 

North America (the United States and Canada): Our Global Generics segment’s revenues from North America (the United States and Canada) for the six months ended September 30, 2018 were Rs.30,168 million, an increase of 3% as compared to the six months ended September 30, 2017. In U.S. dollar absolute currency terms (i.e., U.S. dollars without taking into account the effect of currency exchange rates), such revenues decreased by 2% in the six months ended September 30, 2018 as compared to the six months ended September 30, 2017.

 

During the six months ended September 30, 2018, we launched eight new products in North America (the United States and Canada). These new products include thiotepa injection, buprenorphine and naloxone film, aripiprazole ODT (orally dissolving tablets), levetiracetam bags, OTC esomeprazole, neostigmine injection, hydroxychloroquine injection and Nitro-Dur® patch.

 

India: Our Global Generics segment’s revenues from India were Rs.12,939 million for the six months ended September 30, 2018, an increase of 17% as compared to the six months ended September 30, 2017. During the six months ended September 30, 2018, we launched 15 new brands in India.

 

During the three months ended June 30, 2017, there was a significant reduction in the sales volumes of our existing products, as our customers in India reduced their inventory holdings in anticipation of the transition to India’s Goods and Service Tax (“GST”) regime, which became effective on July 1, 2017. As a result, our revenues from India for the six months ended September 30, 2017 were lower as compared to the revenues for the six months ended September 30, 2018.

 

Emerging Markets: Our Global Generics segment’s revenues from “Emerging Markets” (which is comprised of Russia, other countries of the former Soviet Union, Romania and certain other countries from our “Rest of the World” markets, primarily China, South Africa, and Brazil) for the six months ended September 30, 2018 were Rs.14,135 million, an increase of 26% as compared to the six months ended September 30, 2017.

 

Russia: Our Global Generics segment’s revenues from Russia were Rs.7,581 million for the six months ended September 30, 2018, an increase of 14% as compared to the six months ended September 30, 2017. In Russian rouble absolute currency terms (i.e., Russian roubles without taking into account the effect of currency exchange rates), such revenues increased by 18% for the six months ended September 30, 2018 as compared to the six months ended September 30, 2017. Our over-the-counter (“OTC”) division’s revenues from Russia for the six months ended September 30, 2018 were 40% of our total revenues from Russia, and we intend to further strengthen our OTC sales by continuous branding efforts.

 

According to IQVIA, as per its report for the five months ended August 31, 2018, our sales value (in Russian roubles) growth and volume growth from Russia, as compared to the Russian pharmaceutical market sales value (in Russian roubles) growth and volume growth for the five months ended August 31, 2018, was as follows:

 

   For the five months ended August 31, 2018 
   Dr. Reddy's Laboratories   Russian pharmaceutical
market
 
   Sales value   Volume   Sales value   Volume 
Prescription (Rx)   4.79%   (2.94)%   11.63%   3.12%
Over-the-counter (OTC)   8.46%   0.66%   7.84%   (0.98)%
Total (Rx + OTC)   6.40%   (1.73)%   9.71%   0.29%

  

 44 

 

 

Other Countries of former Soviet Union and Romania: Our Global Generics segment’s revenues from other countries of the former Soviet Union and Romania were Rs.2,623 million for the six months ended September 30, 2018, an increase of 47% as compared to the six months ended September 30, 2017.

 

“Rest of the World” Markets: We refer to all markets of this segment other than North America (the United States and Canada), Europe, Russia, India and other countries of the former Soviet Union and Romania as our “Rest of the World” markets. Our Global Generics segment’s revenues from our “Rest of the World” markets were Rs.3,931 million for the six months ended September 30, 2018, an increase of 41% as compared to the six months ended September 30, 2017. This increase was primarily attributable to an increase in sales contribution from new markets such as Brazil and China.

 

Europe: Our Global Generics segment’s revenues from Europe were Rs.3,930 million for the six months ended September 30, 2018, a decrease of 13% as compared to the six months ended September 30, 2017. This decrease was primarily on account of decrease in prices of our existing products, the foregoing was partially offset by revenues from new products launched between October 1, 2017 and September 30, 2018.

 

Pharmaceutical Services and Active Ingredients (“PSAI”)

 

Our PSAI segment’s revenues for the six months ended September 30, 2018 were Rs.11,438 million, an increase of 11% as compared to the six months ended September 30, 2017. After taking into account the impact of exchange rate fluctuations of the Indian rupee against the multiple currencies in the markets in which we operate, this increase was largely attributable to:

 

·increased sales of active pharmaceutical ingredients for the six months ended September 30, 2018, primarily attributable to increased sales volumes of existing products, partially offset by net impact of changes in sales prices of existing products, which together increased our PSAI segment’s revenues by approximately 5%; and

 

·increased customer orders in our pharmaceutical development services for certain products provided to innovator companies, which increased our PSAI segment’s revenues by approximately 6%.

 

Gross Profit

 

Our total gross profit was Rs.41,625 million for the six months ended September 30, 2018, representing 55.4% of our revenues for that period, as compared to Rs.35,998 million for the six months ended September 30, 2017, representing 52.5% of our revenues for that period.

 

   For the six months ended September 30, 
   2018   2017 
   (Rs. in millions) 
   Gross Profit   % of Segment Revenue   Gross Profit   % of Segment Revenue 
Global Generics  Rs.36,867    60.3%  Rs.32,772    58.4%
PSAI   2,882    25.2%   1,640    15.9%
Proprietary Products   1,247    83.0%   1,051    83.4%
Others   629    58.6%   535    54.5%
Total  Rs.41,625    55.4%  Rs.35,998    52.5%

 

After taking into account the impact of the exchange rate fluctuations of the Indian rupee against multiple currencies in the markets in which we operate, the gross profits from our Global Generics segment increased to 60.3% for the six months ended September 30, 2018, from 58.4% for the six months ended September 30, 2017. This increase was primarily from introduction of new products with higher margins, partially offset by price erosion in some of our key existing products, during the intervening period.

 

The gross profits from our PSAI segment increased to 25.2% for the six months ended September 30, 2018, from 15.9% for the six months ended September 30, 2017. This increase was primarily due to higher realizations in some of our key molecules coupled with changes in our existing product mix (i.e., an increase in the proportion of sales of higher gross margin products and a decrease in the proportion of sales of lower gross margin products).

 

Selling, general and administrative expenses

 

Our selling, general and administrative expenses were Rs.24,478 million for the six months ended September 30, 2018, an increase of 7% as compared to Rs.22,795 million for the six months ended September 30, 2017.

 

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After taking into account the impact of exchange rate fluctuations of the Indian rupee against multiple currencies in the markets in which we operate, this decrease was largely attributable to the following:

 

·an increase in personnel costs, primarily on account of annual raises which increased our selling, general and administrative expenses by approximately 3%;

 

·an increase in freight outward expenses, which increased our selling, general and administrative expenses by approximately 3%; and

 

·an increase in other costs, which increased our selling, general and administrative expenses by approximately 1%.

 

As a proportion of our total revenues, our selling, general and administrative expenses decreased to 32.6% for the six months ended September 30, 2018, from 33.2% for the six months ended September 30, 2017.

 

Research and development expenses

 

Our research and development costs were Rs.8,277 million for the six months ended September 30, 2018, a decrease of 11% as compared to Rs.9,250 million for the six months ended September 30, 2017. Lower spend is primarily on account of certain activities/milestone payments scheduled towards the second half of the fiscal year. Our focus continues on building our pipeline of complex generics, biosimilars and differentiated products.

 

Other (income) / expense, net

 

Our other income was Rs.944 million for the six months ended September 30, 2018, as compared to other income of Rs.308 million for the six months ended September 30, 2017. Other income primarily includes gain of Rs.464 million on account of our sale of rights relating to an intangible asset forming part of our Proprietary products segment and our sale of all of the membership interests in Dr. Reddy’s Laboratories Tennessee, LLC.

 

Finance (expense) / income, net

 

Our net finance income was Rs.781 million for the six months ended September 30, 2018, as compared to net finance income of Rs.197 million for the six months ended September 30, 2017. The increase in net finance income was attributable to:

 

·net interest expense of Rs.43 million for the six months ended September 30, 2018, as compared to net interest expense of Rs.231 million for the six months ended September 30, 2017;

 

·net foreign exchange gain of Rs.603 million for the six months ended September 30, 2018, as compared to net foreign exchange gain of Rs.57 million for the six months ended September 30, 2017; and

 

·profit on sale of investments and unrealized gains on units of mutual funds of Rs.221 million for the six months ended September 30, 2018, as compared to profit on sale of investments of Rs.371 million for the six months ended September 30, 2017.

 

Profit before tax

 

As a result of the above, our profit before tax was Rs.10,787 million for the six months ended September 30, 2018, an increase of 132% as compared to Rs.4,648 million for the six months ended September 30, 2017.

 

Tax expense

 

Our consolidated weighted average tax rate was 11.0% for the six months ended September 30, 2018, as compared to 25.9% for the six months ended September 30, 2017. The effective rate for the six months ended September 30, 2018 was lower as compared to the three months ended September 30, 2017, primarily on account of tax effects arising from unrealized inter-company profits on inventory held in jurisdictions with different tax rates, resolution of a certain tax matter in the our favor resulting in a reversal of income tax expense pertaining to earlier years, and favourable changes in our jurisdictional mix of earnings.

 

Our tax expense was Rs.1,188 million for the six months ended September 30, 2018, as compared to Rs.1,208 million for the six months ended September 30, 2017.

 

Profit for the period

 

As a result of the above, our net profit was Rs.9,599 million for the six months ended September 30, 2018, representing 12.8% of our total revenues for such period, as compared to Rs.3,440 million for the six months ended September 30, 2017, representing 5.0% of our total revenues for such period.

 

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ITEM 3. LIQUIDITY AND CAPITAL RESOURCES

 

We have primarily financed our operations through cash flows generated from operations and a mix of long-term and short-term borrowings. Our principal liquidity and capital needs are for the purchase of property, plant and equipment, regular business operations and research and development.

 

Our principal sources of short-term liquidity are internally generated funds and short-term borrowings, which we believe are sufficient to meet our working capital requirements.

 

Principal Debt Obligations

 

The following table provides a list of our principal debt obligations (excluding finance lease obligations) outstanding as of September 30, 2018:

 

Debt  Amount   Currency(1)  Interest Rate(2)
Pre-shipment credit (short-term)  Rs.20,224   USD  1 Month LIBOR + 01 to 50 bps
Other short-term borrowings   7,631   USD
MXN
UAH
  1 Month LIBOR + 65 to 85 bps
TIIE + 1.25%
21.50%
Long-term borrowings   27,659   USD
EUR
  1 Month LIBOR + 70 to 105 bps
0.81%

 

(1)“MXN” means Mexican pesos and “UAH” means Ukrainian hryvnia.

 

(2)“LIBOR” means the London Inter-bank Offered Rate and “TIIE” means the Equilibrium Inter-banking Interest Rate (Tasa de Interés Interbancaria de Equilibrio).

 

Our long-term borrowings were incurred primarily for the purpose of funding the acquisition of eight ANDAs from Teva Pharmaceutical Industries Limited and to meet certain anticipated capital expenditures.

 

Summary of statements of cash flows

 

The following table summarizes our statements of cash flows for the periods presented:

 

   For the six months ended
September 30,
 
   2018   2017 
Net cash from/(used in):          
Operating activities  Rs.5,706   Rs.4,728 
Investing activities   537    (5,456)
Financing activities   (5,145)   (646)
Net increase/(decrease) in cash and cash equivalents  Rs.1,098   Rs.(1,374)

 

In addition to cash, inventory and accounts receivable, our unused sources of liquidity included Rs.31,120 million available in credit under revolving credit facilities with banks as of September 30, 2018.

 

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Cash Flows from Operating Activities

 

The result of operating activities was a net cash inflow of Rs.5,706 million for the six months ended September 30, 2018, as compared to a cash inflow of Rs.4,728 million for the six months ended September 30, 2017.

 

The increase in net cash inflow of Rs.978 million was primarily due to an increase in our earnings partially offset by an increase in working capital requirements, largely on account of an increase in our trade receivables and inventories as of September 30, 2018.

 

Our average days’ sales outstanding (“DSO”) as at September 30, 2018, March 31, 2018 and September 30, 2017 were 110 days, 102 days and 110 days, respectively. The increase in our DSO between March 31, 2018 and September 30, 2018 was primarily on account of (a) an increase in the credit periods of certain of our customers in North America; and (b) higher exchange rates as of September 30, 2018 as compared to the exchange rates prevailing during the six months ended September 30, 2018, which increased our trade receivables higher than the corresponding revenues.

 

Cash Flows from Investing Activities

 

Our investing activities resulted in a net cash inflow of Rs.537 million and an outflow of Rs.5,456 million for the six months ended September 30, 2018 and 2017, respectively.

 

During the six months ended September 30, 2018, net cash inflow was primarily on account of redemption of investments of Rs.3,482 which was partially offset by a net cash outflow on account of acquisition of property, plant and equipment, and other intangible assets of Rs.3,211.

 

During the six months ended September 30, 2017, net cash outflow was primarily on account of acquisition of property, plant and equipment, and other intangible assets of Rs.6,006 which was partially off-set on account of redemption of investments of Rs.336.

 

Cash Flows from Financing Activities

 

Our financing activities resulted in a net cash outflow of Rs.5,145 million and a net cash outflow of Rs.646 million for the six months ended September 30, 2018 and 2017, respectively.

 

During the six months ended September 30, 2018, the net cash outflow was primarily on account of repayment of short-term borrowings of Rs.290 million, interest payment of Rs.746 million and a dividend pay-out of Rs.4,003 million.

 

During the six months ended September 30, 2017, there was a decrease in net short-term borrowings by Rs.14,961 million, primarily on account of repayment of Rs.23,222 million by our Swiss Subsidiary, which was offset by an increase in long-term borrowings of Rs.19,065 million incurred by our Swiss Subsidiary and our German Subsidiary. Therefore, the net cash outflow of Rs.646 million was primarily on account of dividend pay-out of Rs.3,992 million and interest payments of Rs.684 million partially off-set by an inflow on account of net borrowings incurred of Rs.4,104.

 

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ITEM 4. OTHER MATTERS

 

None.

 

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ITEM 5. EXHIBITS

 

Exhibit Number   Description of Exhibits
     
99.1   Review report of Independent Registered Public Accounting Firm

 

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SIGNATURES

 

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

 

  DR. REDDY’S LABORATORIES LIMITED
(Registrant) 
   
Date:  November 01, 2018 By:   /s/ Sandeep Poddar  
    Name:  Sandeep Poddar 
    Title:  Company Secretary 

 

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