Generon Successfully Concludes First Phase III Clinical Trial of F-627 for Chemotherapy-induced Neutropenia

On January 25, 2018 Generon Corporation, an innovative biotech company in China developing novel biological therapeutics, reported that the first pivotal phase III study in the U.S. for F-627 to treat chemotherapy-induced neutropenia (CIN) in breast cancer patients met the primary endpoint (Press release, Generon (Shanghai), JAN 25, 2018, View Source [SID1234523559]). F-627 (Benegrastim / BineutaTM) is a recombinant human granulocyte colony-stimulating factor (rhG-CSF) dimer with a best-in-class potential to manage CIN in in cancer patients. The primary endpoint was to shorten the duration in days of grade 4 (severe) neutropenia in the first chemotherapy cycle. Patients treated with F-627 demonstrated significantly reduced duration of severe neutropenia compared to patents in placebo group (P<0.0001).

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"We are delighted to announce the significant results seen in this study. This is an important step toward completing the F-627 regulatory package for BLA (biological licensee application) submission" said Dr. David Lacey, Generon’s Chairman of Scientific Advisor board. "We are in the process of further analysis of the data, and plan to submit the results for presentation at an upcoming major medical meeting. " said Dr. Xiaoqiang Yan, Generon’s Chairman and CEO, adding, "Meeting the primary end point of the first pivotal study is an important milestone for Generon, demonstrating our ability to be an innovative biotech company on a global level."

This Phase III trial is a randomized, multi-center, double-blind, placebo controlled Phase III study of the efficacy and safety of a once-per-cycle dose of F-627 in women with stage II-IV breast cancer who are receiving myelotoxic TA chemotherapy treatment (Taxotere (docetaxel) + Adriamycin (doxorubicin)). Subjects were randomized to F-627 or Placebo at 2:1 ratio. About 24 hours after chemotherapy, subjects received either 20 mg fixed dose F-627 or Placebo. The subjects’ absolute neutrophil count (ANC) was measured each day post chemotherapy administration until ANC levels exceeded 2.0 x 109/L, then the ANC value was determined every three days until the next chemotherapy cycle. This is one of two pivotal Phase III studies required for BLA submission in the US. The second Phase III study is under an SPA with the FDA and currently ongoing.

The management executives of Yifan Pharmaceuticals congratulated Generon’s team on this achievement and emphasized their continued confidence in Generon’s ability to pursue F-627’s clinical development toward a successful BLA submission, and to bring the best-in-class rhG-CSF to patients worldwide.

Chemotherapy-induced Neutropenia (CIN)

CIN occurs commonly during current cancer treatments involving cytotoxic chemotherapy. In the U.S. alone, it is estimated that approximately 1.7 million cancer patients receive chemotherapy treatment, which amounts to a total of 7.5 million chemotherapy cycles performed annually with approximately 5.0 million chemotherapy cycles involving CIN. The global CIN market is estimated to be at $7.0 billion with about >85% of patients still on first-generation of rhG-CSFs, and less than 15% of patients using second-generation rhG-CSFs, the pegylated rhG-CSF.

About F-627

F-627 (benegrastim) is under development for the treatment of CIN in cancer patients. F-627 is a recombinant fusion protein containing G-CSF and human IgG2-Fc and is expressed in Chinese Hamster Ovary (CHO) cells. F-627 has an immunoglobulin-like structure. It consists of two G-CSF molecules at the N-terminal of Fc fragments (a G-CSF dimer). G-CSF is a growth factor acting on the neutrophilic lineage in the hematopoietic system. G-CSF binds to specific G-CSF receptors (G-CSFR) on the cell surface and stimulates differentiation, proliferation, and activation of neutrophilic granulocytes. F-627 has showed stronger bioactivities than the monomeric rhG-CSFs in vitro and in vivo.

Teva to Host Conference Call to Discuss Fourth Quarter and Full Year 2017 Financial Results at 8 a.m. ET on February 8, 2018

On January 25, 2018 Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) reported that it will issue a press release on its fourth quarter and full year 2017 financial results on Thursday, February 8, 2018 at 7:00 a.m. ET (Press release, Teva, JAN 25, 2018, View Source;p=RssLanding&cat=news&id=2328502 [SID1234523581]). Following the release, Teva will conduct a conference call and live webcast on the same day, at 8:00 a.m. ET.

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In order to participate, please dial the following numbers (at least 10 minutes before the scheduled start time): United States 1-866-869-2321; Canada 1-866-766-8269 or International +44(0) 203 0095710; passcode: 5279244. For a list of other international toll-free numbers, click here.

A live webcast of the call will also be available on Teva’s website at: www.ir.tevapharm.com. Please log in at least 10 minutes prior to the conference call in order to download the applicable audio software.

Following the conclusion of the call, a replay of the webcast will be available within 24 hours on the Company’s website. The replay can also be accessed until March 8, 2018, 9:00 a.m. ET by calling United States 1-866-247-4222; Canada 1-866-878-9237 or International +44(0) 1452550000; passcode: 5279244.

Myriad to Announce Fiscal Second-Quarter 2018 Financial Results on February 6, 2018

On January 25, 2018 Myriad Genetics, Inc. (NASDAQ:MYGN) reported that it will hold its fiscal second-quarter 2018 sales and earnings conference call with investors and analysts at 4:30 p.m. ET on Tuesday, February 6, 2018 (Press release, Myriad Genetics, JAN 25, 2018, View Source [SID1234523579]). During the call, Mark C. Capone, president and CEO and Bryan Riggsbee, CFO, will provide an overview of Myriad’s financial performance for the fiscal second-quarter and provide a business update.

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To listen to the call, interested parties in the United States may dial 800-699-0623 or +1 303-223-4362 for international callers. All callers will be asked to reference reservation number 21879835. The conference call also will be available through a live webcast and a slide presentation pertaining to the earnings call will also be available under the investor section of our website at www.myriad.com. A replay of the call will be available two hours after the end of the call for seven days and may be accessed by dialing 800-633-8284 within the United States or +1 402-977-9140 for international callers and entering reservation number 21879835.

Janssen to Present 14 Abstracts in Prostate and Urothelial Cancers at ASCO GU 2018, Including New Data on Apalutamide (ARN-509), ZYTIGA® (abiraterone acetate) and Erdafitinib

On January 25, 2018 – New data from the Janseen Pharmaceutical Companies of Johnson & Johnson will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary (ASCO GU) 2018 Cancers Symposium taking place February 8-10 in San Francisco (Press release, Johnson & Johnson, JAN 25, 2018, View Source [SID1234523578]). In total, 14 company-sponsored abstracts with data for both investigational and approved compounds have been accepted for presentation, including for apalutamide and ZYTIGA (abiraterone acetate) in prostate cancer, and for erdafitinib in urothelial cancer. Most notably, Phase 3 data results from the SPARTAN clinical trial, assessing apalutamide in non-metastatic castration-resistant prostate cancer, will be featured as part of the Prostate Cancer Oral Abstract Session on Thursday, February 8.

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"New data featuring approved and investigational compounds continue to demonstrate our commitment to developing novel agents in areas of significant unmet medical need," said Kiran Patel, M.D., Vice President, Clinical Development, Solid Tumors at Janssen Research & Development, LLC. "We are especially excited to present results from the pivotal SPARTAN clinical trial with apalutamide in patients with non-metastatic castration-resistant prostate cancer during this important oncology meeting."

Key company-sponsored data presentations include:

Apalutamide:

SPARTAN, a phase 3 double-blind, randomized study of apalutamide (APA) vs placebo (PBO) in patients (pts) with nonmetastatic castration-resistant prostate cancer (nmCRPC) (Abstract #161)
These data will be presented in Oral Abstract Presentation during Session A of the Prostate Cancer Program from 1:00 pm – 2:30 pm PST on Thursday, February 8th
ZYTIGA:

Abiraterone acetate (AA) plus prednisone (P) 5 mg QD in metastatic castration-naïve prostate cancer (mCNPC): Detailed safety analyses from the LATITUDE phase 3 trial (Abstract #182)
These data will be presented in Poster Presentation Session A from 11:30 am – 1:00 pm and 5:15 pm – 6:15 pm PST on Thursday, February 8th
Medical resource utilization (MRU) of abiraterone acetate plus prednisone (AAP) added to androgen deprivation therapy (ADT) in metastatic castration-naive prostate cancer: Results from LATITUDE (Abstract #201)
These data will be presented in Poster Presentation Session A from 11:30 am – 1:00 pm and 5:15 pm – 6:15 pm PST on Thursday, February 8th
Efficacy and safety of abiraterone acetate (AA) and low-dose prednisone (P) in Japanese patients with newly diagnosed, metastatic, hormone-naïve prostate cancer (mHNPC); Subgroup analysis of LATITUDE trial (Abstract #286)
These data will be presented in Poster Session B from 12:15 pm – 1:45 pm and 6:00 pm – 7:00 pm PST on Friday, February 9th
Erdafitinib:

Erdafitinib (ERDA; JNJ-42756493), a pan-fibroblast growth factor receptor (FGFR) inhibitor, in patients (pts) with metastatic or unresectable urothelial carcinoma (mUC) and FGFR alterations (FGFRa): phase 2 continuous versus intermittent dosing (Abstract #411)
These data will be presented in Rapid Fire Abstract Session during the Urothelial Carcinoma Program from 6:00 pm – 7:00 pm PST on Friday, February 9th
A full list of company-sponsored abstracts to be presented at the meeting follows below:

Abstract No.

Title

Date/Time

Apalutamide

Abstract #161

SPARTAN, a phase 3 double-blind, randomized study of apalutamide (APA) vs placebo (PBO) in patients (pts) with nonmetastatic castration-resistant prostate cancer (nmCRPC)

Oral Abstract Session A

Thursday, February 8th

1:00 pm – 2:30 pm PST

Abstract #27

Association of prostate-specific antigen (PSA) trajectories with risk for metastasis and mortality in non-metastatic castration-resistant prostate cancer (nmCRPC)

Poster Session A

Thursday, February 8th

11:30 am – 1:00 pm
and 5:15 pm – 6:15 pm PST

ZYTIGA

Abstract #182

Abiraterone acetate (AA) plus prednisone (P) 5 mg QD in metastatic castration-naïve prostate cancer (mCNPC): Detailed safety analyses from the LATITUDE phase 3 trial

Poster Session A

Thursday, February 8th

11:30 am – 1:00 pm
and 5:15 pm – 6:15 pm PST

Abstract #201

Medical resource utilization (MRU) of abiraterone acetate plus prednisone (AAP) added to androgen deprivation therapy (ADT) in metastatic castration-naive prostate cancer: Results from LATITUDE

Poster Session A

Thursday, February 8th

11:30 am – 1:00 pm
and 5:15 pm – 6:15 pm PST

Abstract #196

Real-world evidence in patient-related outcomes (PROs) of metastatic castrate-resistant prostate cancer (mCRPC) patients treated with abiraterone acetate plus prednisone (AA+P)

Poster Session A

Thursday, February 8th

11:30 am – 1:00 pm
and 5:15 pm – 6:15 pm PST

Abstract #200

Indirect treatment comparison (ITC) of abiraterone acetate (AA) plus prednisone (P) and docetaxel (DOC) on patient-reported outcomes (PROs) in metastatic castration-naïve prostate cancer (mCNPC)

Poster Session A

Thursday, February 8th

11:30 am – 1:00 pm
and 5:15 pm – 6:15 pm PST

Abstract #217

Neuropsychiatric adverse events of abiraterone acetate and enzalutamide: meta-analysis of randomized clinical trials with real world reporting patterns from EudraVigilance

Poster Session A

Thursday, February 8th

11:30 am – 1:00 pm
and 5:15 pm – 6:15 pm PST

Abstract #286

Efficacy and safety of abiraterone acetate (AA) and low-dose prednisone (p) in Japanese patients with newly diagnosed, metastatic, hormone-naïve prostate cancer (mHNPC); Subgroup analysis of LATITUDE Trial

Poster Session B
Friday, February 9th
12:15 pm – 1:45 pm and 6:00 pm – 7:15 pm PST

Abstract #296

Real-world study of enzalutamide and abiraterone acetate (with prednisone) tolerability (REAAcT) – results

Poster Session B

Friday, February 9th

12:15 pm – 1:45 pm
and 6:00 pm – 7:15 pm PST

Abstract #320

Real world patterns of treatment sequencing in Canada for metastatic castrate-resistant prostate cancer

Poster Session B

Friday, February 9th

12:15 pm – 1:45 pm
and 6:00 pm – 7:15 pm PST

Abstract #321

Patterns of prostate cancer management across Canadian prostate cancer treatment specialists

Poster Session B

Friday, February 9th

12:15 pm – 1:45 pm
and 6:00 pm – 7:15 pm PST

Abstract #343

Evolution of neuropsychiatric adverse events of abiraterone acetate and enzalutamide treatments reported in EudraVigilance, in metastatic castration resistant prostate cancer patients

Poster Session B

Friday, February 9th

12:15 pm – 1:45 pm
and 6:00 pm – 7:15 pm PST

Erdafitinib

Abstract #411

Erdafitinib (ERDA; JNJ-42756493), a pan-fibroblast growth factor receptor (FGFR) inhibitor, in patients (pts) with metastatic or unresectable urothelial carcinoma (mUC) and FGFR alterations (FGFRa): Phase 2 continuous versus intermittent dosing

Rapid Fire Abstract Session
(Oral Abstract Presentation)

Friday, February 9th

6:00 pm – 7:00 pm PST

Abstract #450

Efficacy of programmed death 1 (PD-1) and programmed death 1 ligand (PD-L1) inhibitors in patients with FGFR mutations and gene fusions: Results from a data analysis of an ongoing phase 2 study of erdafitinib (JNJ-42756493) in patients (pts) with advanced urothelial cancer (UC)

Poster Session B

Friday, February 9th

12:15 pm – 1:45 pm
and 6:00 pm – 7:15 pm PST

About ZYTIGA
ZYTIGA (abiraterone acetate) is indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). ZYTIGA blocks CYP17-mediated androgen production, which fuels prostate cancer growth, at three sources: in the testes, adrenals and the prostate tumor tissue.

Since its first approval in the U.S. in 2011, ZYTIGA has been approved in combination with prednisone/prednisolone in 105 countries. More than 330,000 men worldwide, including 113,000 in the U.S., have received treatment with it, and it was the number one prescribed oral medication in the U.S. for men with mCRPC in 2016.

For more information about ZYTIGA, visit www.ZYTIGA.com.

Important Safety Information – ZYTIGA

CONTRAINDICATIONS – ZYTIGA (abiraterone acetate) is not indicated for use in women. ZYTIGA can cause fetal harm (Pregnancy Category X) when administered to a pregnant woman and is contraindicated in women who are or may become pregnant.

Hypertension, Hypokalemia and Fluid Retention Due to Mineralocorticoid Excess – Use with caution in patients with a history of cardiovascular disease or with medical conditions that might be compromised by increases in blood pressure, hypokalemia, or fluid retention. ZYTIGA may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition. Safety has not been established in patients with LVEF <50% or New York Heart Association (NYHA) Class III or IV heart failure (in Study 1) or NYHA Class II to IV heart failure (in Study 2) because these patients were excluded from these randomized clinical trials. Control hypertension and correct hypokalemia before and during treatment. Monitor blood pressure, serum potassium, and symptoms of fluid retention at least monthly.

Adrenocortical Insufficiency (AI) – AI was reported in patients receiving ZYTIGA in combination with prednisone, after an interruption of daily steroids and/or with concurrent infection or stress. Use caution and monitor for symptoms and signs of AI if prednisone is stopped or withdrawn, if prednisone dose is reduced, or if the patient experiences unusual stress. Symptoms and signs of AI may be masked by adverse reactions associated with mineralocorticoid excess seen in patients treated with ZYTIGA. Perform appropriate tests, if indicated, to confirm AI. Increased dosages of corticosteroids may be used before, during, and after stressful situations.

Hepatotoxicity – In post-marketing experience, there have been ZYTIGA-associated severe hepatic toxicities, including fulminant hepatitis, acute liver failure and deaths. Monitor liver function and modify, withhold, or discontinue ZYTIGA dosing as recommended (see Prescribing Information for more information). Measure serum transaminases [alanine aminotransferase (ALT) and aspartate aminotransferase (AST)] and bilirubin levels prior to starting treatment with ZYTIGA, every two weeks for the first three months of treatment, and monthly thereafter. Promptly measure serum total bilirubin, AST, and ALT if clinical symptoms or signs suggestive of hepatotoxicity develop. Elevations of AST, ALT, or bilirubin from the patient’s baseline should prompt more frequent monitoring. If at any time AST or ALT rise above five times the upper limit of normal (ULN) or the bilirubin rises above three times the ULN, interrupt ZYTIGA treatment and closely monitor liver function. Re-treatment with ZYTIGA at a reduced dose level may take place only after return of liver function tests to the patient’s baseline or to AST and ALT less than or equal to 2.5X ULN and total bilirubin less than or equal to 1.5X ULN.

Permanently discontinue ZYTIGA for patients who develop a concurrent elevation of ALT greater than 3X ULN and total bilirubin greater than 2X ULN in the absence of biliary obstruction or other causes responsible for the concurrent elevation.

Adverse Reactions – The most common adverse reactions (≥10%) are fatigue, joint swelling or discomfort, edema, hot flush, diarrhea, vomiting, cough, hypertension, dyspnea, urinary tract infection and contusion.

The most common laboratory abnormalities (>20%) are anemia, elevated alkaline phosphatase, hypertriglyceridemia, lymphopenia, hypercholesterolemia, hyperglycemia, elevated AST, hypophosphatemia, elevated ALT and hypokalemia.

Drug Interactions – Based on in vitro data, ZYTIGA is a substrate of CYP3A4. In a drug interaction trial, co-administration of rifampin, a strong CYP3A4 inducer, decreased exposure of abiraterone by 55%. Avoid concomitant strong CYP3A4 inducers during ZYTIGA treatment. If a strong CYP3A4 inducer must be co-administered, increase the ZYTIGA dosing frequency only during the co-administration period [see Dosage and Administration (2.3)]. In a dedicated drug interaction trial, co-administration of ketoconazole, a strong inhibitor of CYP3A4, had no clinically meaningful effect on the pharmacokinetics of abiraterone.

ZYTIGA is an inhibitor of the hepatic drug-metabolizing enzymes CYP2D6 and CYP2C8. Avoid co-administration with CYP2D6 substrates with a narrow therapeutic index. If alternative treatments cannot be used, exercise caution and consider a dose reduction of the CYP2D6 substrate drug. In a CYP2C8 drug interaction trial in healthy subjects, the AUC of pioglitazone, a CYP2C8 substrate, was increased by 46% when administered with a single dose of ZYTIGA. Patients should be monitored closely for signs of toxicity related to a CYP2C8 substrate with a narrow therapeutic index if used concomitantly with ZYTIGA.

Use in Specific Populations – Do not use ZYTIGA in patients with baseline severe hepatic impairment (Child-Pugh Class C).

About Apalutamide (ARN-509)
Apalutamide is an investigational, next-generation oral androgen receptor inhibitor that blocks the androgen signaling pathway in prostate cancer cells, and prevents binding of androgen to the androgen receptor and translocation of the androgen receptor to the nucleus of the cancer cell.

About Erdafitinib
Erdafitinib is a pan-fibroblast Growth Factor Receptor (FGFR) tyrosine kinase inhibitor currently being evaluated by Janssen in Phase 2 and 3 clinical trials in patients with advanced urothelial cancer. Additional research is also being conducted to explore the use of erdafitinib in other cancer indications.

Dr. Reddy’s Q3 and 9M FY18 Financial Results

On January 25, 2018 Dr. Reddy’s Laboratories Ltd. (BSE: 500124 | NSE: DRREDDY | NYSE: RDY) reported its consolidated financial results for the third quarter and nine months ended December 31, 2017 under International Financial Reporting Standards (IFRS) (Press release, Dr Reddy’s, JAN 25, 2018, View Source [SID1234523576]).

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Q3 Performance Summary 9M Performance Summary

Rs. 3,806 Cr Rs. 10,668 Cr
Revenue Revenue
[Up: 7% QoQ, Up: 3% YoY] [Up: 1% YoY]

56.3% 53.8%
Gross Margin Gross Margin
[Q2 FY18: 53.3%; Q3 FY17: 59.1%]
[9M FY17: 57.2%]


Rs. 1,205 Cr Rs. 3,484 Cr
SGNA expenses SGNA expenses
[Up: 6% YoY] [Down: 2% YoY]

Rs. 467 Cr Rs. 1,392 Cr
R&D expenses R&D expenses
[12.3% of Revenues] [13.0% of Revenues]

Rs. 806 Cr Rs. 1,830 Cr
EBITDA EBITDA
[21.2% of Revenues] [17.2% of Revenues]

Rs. 334 Cr* Rs. 678 Cr*
Profit after Tax Profit after Tax
[8.8% of Revenues] [6.4% of Revenues]

* During Q3 FY18, the ‘Tax Cuts and Jobs Act of 2017’ was approved and enacted in the United States. Consequent to this enactment the deferred tax assets and liabilities of the US entity have been re-measured resulting in a one-time charge of Rs. 93 Crores. [Adjusted PAT for Q3 FY 18: Rs. 427 Crores and 9M FY 18: Rs. 771 Crores]

Commenting on the results, CEO and Co-chairman, G.V. Prasad said "We had a satisfactory third quarter performance, with all our key markets performing well. We recorded sequential revenue growth of 7%, despite continuing challenges such as price erosion in the U.S. Our first-cycle NDA approval of Impoyz is a significant milestone in the commercialization of our proprietary products pipeline. We will continue our focus on operational excellence and controlling of SG&A costs across the organisation".

All amounts in millions, except EPS All US dollar amounts based on convenience translation rate of I USD = Rs. 63.83

Dr. Reddy’s Laboratories Limited and Subsidiaries

Consolidated Income Statement

Q3 FY 18 Q3 FY 17 Growth
Particulars ($) (Rs.) % ($) (Rs.) % %
Revenues 596 38,060 100.0 581 37,065 100.0 3
Cost of revenues 261 16,649 43.7 238 15,166 40.9 10
Gross profit 335 21,411 56.3 343 21,899 59.1 (2 )
Operating Expenses
Selling, general & administrative expenses 189 12,048 31.7 178 11,341 30.6 6
Research and development expenses 73 4,667 12.3 78 4,956 13.4 (6 )
Other operating expense / (income) (5 ) (313 ) (0.8 ) (3 ) (187 ) (0.5 ) 67
Results from operating activities 78 5,009 13.2 91 5,789 15.6 (13 )
Finance expense / (income), net (13 ) (851 ) (2.2 ) (1 ) (44 ) (0.1 ) 1850
Share of (profit) of equity accounted investees, net of income tax (1 ) (85 ) (0.2 ) (1 ) (89 ) (0.2 ) (5 )
Profit before income tax 93 5,945 15.6 93 5,922 16.0 0
Income tax expense 41 2,601 * 6.8 19 1,221 3.3 113
Profit for the period 52 3,344 8.8 74 4,701 12.7 (29 )

Diluted EPS 0.32 20.13 0.44 28.32 (29 )

* ~Rs. 930 million impact on account of reforms in US tax laws

EBITDA Computation

Q3 FY 18 Q3 FY 17
Particulars ($) (Rs.) ($) (Rs.)
Profit before income tax 93 5,945 93 5,922
Interest (income) / expense net* (14 ) (881 ) (1 ) (53 )
Depreciation 33 2,089 30 1,936
Amortization 14 882 15 956
Impairment 0.3 20 0.5 32
EBITDA 126 8,055 138 8,793
EBITDA (% to revenues) 21.2 23.7

* – Includes income from Investments

Key Balance Sheet Items

As on 31st Dec 17 As on 30th Sep 17
Particulars ($) (Rs.) ($) (Rs.)
Cash and cash equivalents and Other current Investments 344 21,958 263 16,793
Trade receivables (current) 665 42,432 661 42,203
Inventories 420 26,825 423 26,998
Property, plant and equipment 912 58,189 907 57,905
Goodwill and Other Intangible assets 755 48,182 778 49,634
Loans and borrowings (current & non-current) 860 54,911 841 53,668
Trade payables 228 14,575 222 14,193
Equity 1,938 1,23,685 1,909 1,21,840

All amounts in millions, except EPS All US dollar amounts based on convenience translation rate of I USD = Rs. 63.83

Revenue Mix by Segment [Year on year]

Q3 FY 18 Q3 FY 17 Growth
Particulars ($) (Rs.) % ($) (Rs.) % %
Global Generics 472 30,105 79 480 30,638 83 -2
North America 16,073 16,595 -3
Europe* 2,006 2,148 -7
India 6,126 5,947 3
Emerging Markets# 5,900 5,948 -1
PSAI 85 5,436 14 85 5,400 14 1
North America 863 1,259 -31
Europe 1,572 1,828 -14
India 627 409 53
Rest of World 2,374 1,904 25
Proprietary Products & Others 39 2,519 7 16 1,027 3 145
Total 596 38,060 100 581 37,065 100 3

Revenue Mix by Segment [Sequential]

Q3 FY 18 Q2 FY 18 Growth
Particulars ($) (Rs.) % ($) (Rs.) % %
Global Generics 472 30,105 79 448 28,618 81 5
North America 16,073 14,318 12
Europe* 2,006 2,424 -17
India 6,126 6,370 -4
Emerging Markets# 5,900 5,506 7
PSAI 85 5,436 14 89 5,654 16 -4
North America 863 962 -10
Europe 1,572 1,938 -19
India 627 436 44
Rest of World 2,374 2,318 2
Proprietary Products & Others 39 2,519 7 19 1,188 3 112
Total 596 38,060 100 556 35,460 100 7

* Europe primarily includes Germany, UK and out licensing sales business

# Emerging Markets refers to Russia, other CIS countries, Romania and Rest of the World markets including Venezuela

Segmental Analysis

Global Generics (GG)

Revenues from GG segment at Rs. 30.1 billion.

Sequential growth of 5%, primarily driven by the US and Emerging Markets

Year-on-year decline of 2%, primarily on account of adverse foreign exchange as the US dollar depreciated by ~4% and lower contribution from Europe generics market.

· Revenues from North America at Rs. 16.1 billion.

- Sequential growth of 12%, primarily on account of contribution from new products major being sevelamer carbonate

- Year-on-year decline of 3%, primarily on account of higher price erosions due to channel consolidation and increased competition in some of our key molecules, and impact of adverse foreign exchange. The above is partly offset by new products contribution.

As of 31st December 2017, cumulatively 102 generic filings are pending for approval with the USFDA (99 ANDAs and 3 NDAs under 505(b)(2) route). Of these 99 ANDAs, 59 are Para IVs out of which we believe 29 have ‘First to File’ status.

· Revenues from Emerging Markets at Rs. 5.9 billion

- Revenues from Russia at Rs. 3.4 billion. Year-on-year growth of 9%. In constant currency i.e. in Rouble terms year-on-year growth is 5%.

- Revenues from other CIS countries and Romania market at Rs. 1.0 billion. Year-on-year decline of 2%.

- Revenues from Rest of World (RoW) territories at Rs. 1.5 billion. Year-on-year decline of 17%.

· Revenues from India at Rs. 6.1 billion. Year-on-year growth of 3%. Normalizing for the GST transition related adjustments, the comparable growth is ~11%.

· Revenues from Europe at Rs. 2.0 billion. Year-on-year decline of 7%, primarily on account of higher price erosion in some of the key molecules coupled with temporary supply disruptions.

Pharmaceutical Services and Active Ingredients (PSAI)

· Revenues from PSAI at Rs. 5.4 billion. Year-on-year growth of 1%.

· During the quarter, 13 DMFs were filed globally of which 1 was in the US. The cumulative number of DMF filings as of 31st December, 2017 was 791.

Proprietary Products (PP)

· Revenues from PP at Rs. 2.1 billion

During Q3 FY18 USFDA approved IMPOYZ (clobetasol propionate) Cream 0.025%. In line with the existing outlicensing agreement with Encore Dermatology Inc. this approval triggered milestone recognition of Rs. 1.3 billion during Q3 FY18.

Income Statement Highlights:

· Gross profit margin at 56.3%.

- Improved by ~300 bps sequentially, aided by better product mix and milestone receipt of Rs. 1.3 billion in Proprietary Products

- Declined by ~280 bps over that of previous year primarily on account of higher price erosions, increased competitive intensity in some of our key molecules in the US and adverse foreign exchange impact.

- Gross profit margin for GG and PSAI business segments are at 59.5% and 23.8% respectively.

· SG&A expenses at Rs. 12.0 billion, an increase of 6%. During the quarter, a settlement agreement was entered into with the US Department of Justice on the litigation involving packaging against a payout of Rs. 319 million. The balance increase is on account of sales & marketing and other spends towards events specific to the quarter.

· Research & development expenses at Rs. 4.7 billion, a decrease of 6%. As % to Revenues- Q3 FY18: 12.3% | Q2 FY 18: 11.8% | Q3 FY17: 13.4%. Focus continues on building complex generics, biosimilars and differentiated products pipeline.

· Net Finance income at Rs. 851 million compared to Rs. 44 million in Q3FY17. The incremental income of Rs. 807 million is on account of:

- Increase in profit on sales of investments by Rs. 698 million.

- Increase in net interest income by Rs. 129 million.

- Net foreign exchange loss of Rs. 30 million in the current quarter vs net foreign exchange loss of Rs. 10 million in the previous year.

· Profit after Tax at Rs. 3.3 billion. During the quarter, the ‘Tax Cuts and Jobs Act of 2017’ was approved and enacted in the United States. Consequent to this enactment the deferred tax assets and liabilities in the US entity have been re-measured resulting in a one-time charge of Rs. 930 million being recorded under tax expense.

· Diluted earnings per share is at Rs. 20.13

· Capital expenditure is at Rs. 2.2 billion.

Earnings Call Details (06:30 pm IST, 08:00 am EST, January 25, 2018)

The Company will host an earnings call to discuss the performance and answer any questions from participants. This call will be accessible through an audio dial-in and a web-cast.

Audio conference Participants can dial-in on the numbers below

Primary number: 91 22 3960 0616
Secondary number: 91 22 6746 5826
International Toll Free Number USA 18667462133
UK 08081011573
Singapore 8001012045
Hong Kong 800964448

Playback of call: 91 22 3065 2322, 91 22 6181 3322
Conference ID: 375#
Web-cast More details will be provided through our website, www.drreddys.com

Transcript of the event will be available at www.drreddys.com. Playback will be available for a few days.