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Annual Update

June 22, 2016


Sector View

Healthcare Annual Update

Neutral
Stocks Performance ( % Returns as on March 31, 2016)
Company
Jubilant Life

1Y

2Y

3Y

5Y FY17 (YTD)

173

162

143

153

-17

Alembic Pharma

32

113

488

NA

-22

Aurobindo Pharma

22

191

921

660

-18

Torrent Pharma.

16

156

285

362

-7

Ajanta Pharma

15

254

719

5176

10

Glaxosmit Pharma

11

48

73

85

Divi's Lab.

11

45

100

193

-4

Unichem Labs.

-4

27

16

-3

Biocon

14

77

40

40

Glenmark Pharma.

41

72

180

-17

Natco Pharma

-2

158

381

650

-13

Apollo Hospitals

-3

45

58

181

-11

CNX 500

-8

23

45

39

Strides Arcolab

-8

180

24

194

-16

Ipca Labs.

-8

-31

10

94

-34

Nifty

-9

15

36

33

Cadila Health.

-9

55

113

101

-4

Dr Reddy's Labs

-13

18

72

85

-2

CNX Pharma

-14

44

85

142

-10

Pfizer

-20

41

69

44

-20

Sun Pharma.Inds.

-20

43

100

271

-10

Indoco Remedies

-20

107

400

390

-19

Lupin

-26

59

135

255

-21

Cipla

-28

34

35

59

-26

Syngene Int

NA

NA

NA

NA

-2

YTD: till 20-June-2016

Currency Movement
140
130
120
110
100
90
80
Mar-16

Jan-16

Nov-15

Sep-15

Jul-15

May-15

Mar-15

70

USDINR

EUROINR

RUBINR

BRLINR

JPYINR

ZARINR

Price movement
140
130
120
110
100
90
80
70

CNX Pharma

Mar-16

Jan-16

Nov-15

Sep-15

Jul-15

May-15

Mar-15

60

Nifty

Research Analyst
Siddhant Khandekar
siddhant.khandekar@icicisecurities.com
Mitesh Shah
mitesh.sha@icicisecurities.com
Nandan Kamat
nandan.kamat@icicisecurities.com

ICICI Securities Ltd. | Retail Equity Research

Course correction drive after turbulent FY16...


FY16 turned out to be a demanding fiscal for pharma players after a near
hassle-free ride for five years. This was attributable to the triple whammy
impact of 1) USFDA issues (483s and warning letters), 2) NLEM/FDC
impact in the domestic market and 3) political turmoil and adverse
currency shock in EMs. Indian companies received nine USFDA warning
letters in FY16, by far the highest run rate over the years. What came as a
surprise even for industry players was the frequency of inspections and
the random nature of issues flagged in the scrutiny. Paradoxically,
however, the fiscal also witnessed highest ever ANDA approvals for
Indian companies (177 approvals vs. 92 in FY15). However, investors, by
and large, remained sceptical as almost all players received either
warning letters or critical Form 483 observations.
Despite the regulatory turmoil, US sales of a select pack of I-Direct
universe (~37% of universe revenues) grew ~14% YoY in FY16 thanks
to accelerated approvals and exclusivity launches by Lupin (gGlumetza;
anti-diabetic), Torrent (gAbilify; CNS) and Sun Pharma (gGleevec; anticancer)) besides consolidation of new acquisitions (Natrol by
Aurobindo). Note that US growth has not captured gNexium (GI) traction
for Cipla and gAbilify traction for Alembic for nondisclosure of specific
traction. Companies like Glenmark and Cadila have also registered strong
YoY growth.
Domestic formulations from the select pack (~24% of universe revenues)
grew ~11% YoY in FY16. The below-normal growth can be attributed to
NLEM/FDC impact and, to some extent, also to the higher base of FY15.
Among companies, Ajanta, Glenmark, Lupin, Cipla, Dr Reddys, Sun and
Torrent witnessed strong growth.
Most companies spent heavily on R&D and also guided for incremental
R&D spend in the next few years. Likewise, the capex spend also went up
significantly as companies invested in augmenting capacity to mitigate
the regulatory impact and debottlenecking besides out-bound
acquisitions (Gavis by Lupin and InvaGen by Cipla among others).
Overall, the R&D spend as a percentage of sales was at 7.7% for the IDirect universe with some large caps committing even excess of 12% for
the future. Similarly, capex spend for the fiscal was at | 15398 crore, by
far the highest in recent years.
Pharma in metamorphosis mode; valuations reflect near term headwinds
After enjoying a near seamless journey in the US, thanks to the patent
cliff ride, the companies are facing headwinds not only in the US but also
in India and some important emerging markets, as discussed earlier. By
virtue of this, most stocks are down between 20% and 40% from their
FY16 peaks. The companies are bracing for the new normal whereby
frequent and random USFDA audits will be common as will be the cost
on remediation and improvement besides capex for alternate
arrangements. Secondly, the R&D spend is likely to spike as companies
prepare for complex launches in the US such as oncology injectables,
respiratory, derma, ophthalmic and biosimilars to mitigate the pricing
impact and consolidation. However, this metamorphosis is fraught with
front-loaded costs and longer gestation periods. We prefer companies
that are best placed to tackle the new challenges. Our top picks are
Lupin, Dr Reddys, Torrent Pharma, Natco and Syngene. USFDA, NLEM
and FDCs related issues are likely to weigh in the near term.

US remains market to conquer but new challenges emerge


We divide the success story of Indian generic players in the US into two
phases - FY06-11 and FY11-16. While the first phase witnessed heavy
capex followed by growing US generic opportunities, the early part of
the FY11-16 phase witnessed robust incremental free cash flows on the
back of exclusivity launches and the extensive piggyback impact of the
impending patent cliff.
Passing of the Generic Drugs User Fee act (GUDUFA) and Affordable
Care Act also lifted the generics usage and, in turn, the fortunes of Indian
generic exporters. However, the latter was marred by frequent recalls,
increased USFDA scrutiny especially time taken between inspection and
issuance of warning letter, pricing pressure due to buyer consolidation
and waning impact of the generic patent cliff.
Exhibit 1: US sales grow 66.3% in FY06-11

Exhibit 2: US sales grow 28.8% in FY11-16


50000.0

40000.0

40000.0

30000.0

30000.0

20000.0
10000.0

970.3

3804.2

3972.3

FY07

FY08

7220.5

9692.7

12355.5

| crore

| crore

50000.0

20000.0

43739.1
32493.5

12355.5

18321.5

37316.9

23042.1

10000.0
0.0

0.0
FY06

FY09

FY10

FY11

FY11

FY12

FY13

FY14

FY15

FY16

US Sales

US Sales

Source: Company, ICICIdirect.com, Research

Source: Company, ICICIdirect.com Research

We believe Indian pharma players are at an inflection point as they plan


to mitigate the US based risks by 1) improving quality checks, 2) higher
investments in back-up arrangements, 3) augmented R&D to move away
from plain vanilla generics and exploiting complex and untapped areas
such as biosimilars and 4) outbound M&As including brands and select
portfolios. Large cap players such as Lupin and Cipla acquired US based
players to establish the manufacturing base in that country whereas Dr
Reddys was busy in brand acquisitions. We also noted a changed
strategy on part of Indian players, especially in the innovative space,
whereby MNCs are offering their pipeline to Indian companies to take it
forward for late stage R&D and marketing (Sun-MSD deal and Dr
Reddys-Xenoport deal).
Exhibit 3: I-Direct Universe capex FY06-11

Exhibit 4: I-Direct universe capex (FY11-18E)

20000

20000

18375
15233

15000

15000

10498

5000

2872

3760

5711

7447
4282

10000

| crore

| crore

8889

10000

7447

8023

FY11

FY12

10323

8383

7276

5000
0

0
FY06

FY07

FY08

FY09

FY10

FY11

FY13

FY14

ICICI Securities Ltd. | Retail Equity Research

FY16

FY17E FY18E

Capex

Capex

Source: Company, ICICIdirect.com Research

FY15

Source: Company, ICICIdirect.com, Research

Page 2

Exhibit 5: I-Direct Universe R&D FY06-11

Exhibit 6: I-Direct Universe R&D FY11-18E

10.0

10.0

8.0

8.0

6.0

5.5

4.8

4.6

4.0

5.3

4.4

4.1

6.0

5.3

6.8

6.4

5.7

5.4

7.9

8.9

8.8

4.0
2.0

2.0

0.0

0.0
FY06

FY07

FY08

FY09

FY10

FY11

FY11

FY12

FY13

I-Direct R&D as % of Sales

FY14

FY15

FY16

FY17E

FY18E

I-Direct R&D as % of Sales

Source: Company, ICICIdirect.com Research

Source: Company, ICICIdirect.com, Research

Exhibit 7: Top five companies R&D as percentage of sales

Exhibit 8: Others with significant spike in R&D as percentage of sales

12.0
11.5

13.0
11.3

14.0
12.0
10.0
8.0
6.0
4.0
2.0
0.0

7.6

10.5
9.9

9.0
7.1

6.1

5.1

Sun Pharma

6.9

Lupin

6.5

4.4

Dr. Reddy's
Labs
FY12

8.0

FY16

Cipla

14.0
12.0
10.0
8.0
6.0
4.0
2.0
0.0

12.0
9.8
5.5

7.0

7.4

8.0
4.0

7.7
6.9
4.3

4.3

2.2

4.5

1.9

Alembic
Pharma

Glenmark

6.1

Ajanta
Pharma

FY18E

Cadila
Healthcare

FY12

FY16

Torrent
Pharma

Indoco
Remedies

FY18E

Source: Company, ICICIdirect.com, Research

Source: Company, ICICIdirect.com Research

The new investments are likely to take more time to mature because of
the changed rules of the game and also due to crowding in existing
opportunities. Despite receipt of nine warning letters (by far the highest
in any fiscal) there were as many as 177 approvals, also the highest. This
suggests that the approval machinery is on and running. Although there
will be some windfalls due to FTF launches, we expect a major change of
course in the strategy beyond FY18.
Exhibit 9: Warning letters (highest in FY16)

Exhibit 10: ANDA approvals (highest in FY16)

10

8
6

150

177
138

119

106

92

100
50

29

35

35

22

44

Warning Letters

Source: USFDA, ICICIdirect.com Research

FY16

FY15

FY12

FY11

FY10

FY07

FY06

FY09

FY08

FY14

FY13

4
2

200

FY12

FY13
Final Approvals

FY14

FY15

FY16

Tentative Approvals

Source: USFDA, ICICIdirect.com, Research

For FY16-18E, the I-direct universe of the select US pack is likely to grow
at a CAGR of 14.4% to | 55339 crore. Companies like Lupin, Glenmark,
Cadila and Aurobindo are likely to post good growth whereas Sun,
Alembic and Torrent are likely to be laggards.

ICICI Securities Ltd. | Retail Equity Research

Page 3

NLEM additions for domestic formulations likely to continue; FDC new


headache
In FY16, besides extension of the NLEM list (NLEM 2015) by NPPA, the
companies were also hit by negative adjustment for NLEM portfolio- in
synch with negative WPI for FY16. However, the major unforeseen event
was banning of 344 fixed dosages combination (FDCs) over safety
concerns. In 2014, the government formed a panel (Kokate panel) to
review over 6,000 FDCs that were able to penetrate the market after
approval from only individual state regulators and not from the central
government, which is a legal necessity. Although companies contested
the ban in the Delhi High Court, which subsequently stayed the order, the
abrupt government action had its impact on the banned drugs sales due
to channel disturbance. Also note that the panel has notified 963 FDCs as
irrational so the fate of the remaining 619 is still hanging in balance. This
suggests that smooth sailing in the Indian formulations space is likely to
be a thing of past as companies will have to introduce new products and
push for more volumes for growth. In this scenario, we expect the annual
growth trajectory for Indian formulations to come down from 13-15% to
10-12%, going ahead.
For FY16-18E, the I-direct universe select pack is likely to grow at a CAGR
of 15.4% to | 33606 crore. Companies like Ajanta, Alembic, Glenmark,
Sun and Dr Reddys are likely to post good growth whereas Biocon,
Cadila, Ipca and Torrent are likely to be laggards.
Exhibit 11: Impact NLEM 2015, FDC ban and negative WPI
(| crore)
COMPANY

Full Value

NLEM 15 - New

FDC's

WPI

MAT VAL

Total

% Impact

MAT VAL

% Impact

MAT VAL

% Impact

MAT VAL

% Impact

IPM

98042.2

4460.7

4.5

877.5

0.9

3049.3

3.1

534.0

0.5

Glenmark

2346.7

192.3

8.2

42.0

1.8

141.8

6.0

8.5

0.4

Lupin

3405.4

113.0

3.3

32.1

0.9

63.3

1.9

17.6

0.5

Cipla

4886.4

136.6

2.8

78.1

1.6

26.2

0.5

32.4

0.7

Zydus

3810.9

105.2

2.8

59.7

1.6

18.1

0.5

27.4

0.7

Sun

8643.8

230.5

2.7

97.8

1.1

87.3

1.0

45.4

0.5

Dr Reddy's

2420.7

64.1

2.6

36.0

1.5

13.1

0.5

14.9

0.6

Torrent

2271.7

39.7

1.7

12.5

0.6

12.1

0.5

15.0

0.7

Abbott Healthcare

3148.9

500.7

15.9

8.4

0.3

473.3

15.0

19.0

0.6

Pfizer

2871.9

441.8

15.4

52.2

1.8

365.7

12.7

24.0

0.8

Macleods

2828.9

364.1

12.9

12.3

0.4

338.3

12.0

13.4

0.5

Micro

1842.3

97.8

5.3

17.6

1.0

70.4

3.8

9.8

0.5

Mankind

3655.6

185.7

5.1

1.9

0.1

169.5

4.6

14.3

0.4

Alkem

3045.2

142.0

4.7

44.5

1.5

75.4

2.5

22.1

0.7

Aristo

2425.5

80.5

3.3

1.5

0.1

61.9

2.6

17.1

0.7

USV

1951.6

64.7

3.3

8.2

0.4

47.8

2.4

8.7

0.4

Intas

2770.9

88.7

3.2

27.6

1.0

48.5

1.7

12.7

0.5

Sanofi

2357.8

72.2

3.1

45.3

1.9

9.7

0.4

17.2

0.7

GSK

3197.8

94.9

3.0

12.0

0.4

54.1

1.7

28.9

0.9

Abbott India

1973.4

26.1

1.3

14.5

0.7

5.6

0.3

6.0

0.3

Source: AIOCD, ICICIdirect.com Research

ICICI Securities Ltd. | Retail Equity Research

Page 4

Exhibit 12: Growth trends in Indian formulations market in FY16 (secondary market)
25
22.9
20

18.8
15.8

15

Revenues
17.0
10.0
15.9
13.0
15.5
15.5
16.2
16.1
10.6
16.1
21.0
11.9
13.3
18.7
16.7
9.4
24.2
-0.8
16.8

EBITDA
16.6
-13.9
29.2
14.4
16.0
13.0
15.7
14.5
9.1
19.9
31.4
38.7
17.0
21.7
15.1
13.0
26.8
-21.1
29.1

6.6

Mar-16

Feb-16

Jan-16

Dec-15

Nov-15

Oct-15

Sep-15

Aug-15

IPM Growth (%)

Source: AIOCD Data base, ICICIdirect.com Research

Exhibit 13: Growth in key therapeutic segments in FY16


25

14.6

15
10

21.2

19.6

20

16.4
10.8

20.3

17.4

16.9

16.2
13.4

12.5 12.5

15.3

14.2

13.1

10.5

8.5

12.2

1.6
Sex Stimulants

Anti Malarials

Others

Urology

Blood Related

Vaccines
AntiNeoplastics
Ophthal

Hormones

Gynaecological

Derma

Respiratory
Pain /
Analgesics
Neuro / Cns

Source: AIOCD Data base, ICICIdirect.com Research

Expected CAGR in FY16-18E


Ajanta Pharma
Alembic Pharma
Apollo Hospitals
Aurobindo Pharma
Biocon
Cadila Healthcare
Cipla
Divi's Labs
Dr Reddy's Labs
Glenmark Pharma
Indoco Remedies
Ipca laboratories
Jubilant
Lupin
Natco Pharma
Sun Pharma
Syngene Int
Torrent Pharma
Unichem Laboratories

9.6

Anti-Infectives

Profit
52.6
62.5
6.2
85.6
20.5
32.3
-0.2
21.7
13.1
13.2
25.9
-29.8
40.9
19.8
28.9
18.0
29.1
65.6
-0.5

12.2

9.6

(%)

Ajanta Pharma
Alembic Pharma
Apollo Hospitals
Aurobindo Pharma
Biocon
Cadila Healthcare
Cipla
Divi's Labs
Dr Reddy's Labs
Glenmark Pharma
Indoco Remedies
Ipca laboratories
Jubilant
Lupin
Natco Pharma
Sun Pharma
Syngene Int
Torrent Pharma
Unichem Laboratories

EBITDA
37.6
57.9
8.7
51.7
14.6
26.3
4.4
19.6
13.2
16.8
23.1
-18.0
7.4
17.8
21.4
20.4
28.2
59.7
-2.0

12.5

10.4

10

Financial CAGR in FY13-16


Revenues
22.7
27.0
17.1
32.8
11.8
15.5
18.0
20.2
9.9
15.4
16.6
0.8
3.9
13.7
19.6
35.8
26.0
28.2
7.2

13.6

13.4

13.0

Jul-15

Profit
51.4
54.4
12.5
27.7
19.5
16.5
8.8
20.5
17.0
14.6
11.0
-11.2
13.4
21.4
23.7
22.3
52.1
49.1
3.2

Jun-15

EBITDA
43.3
44.4
13.3
26.8
6.9
18.4
13.2
22.4
18.9
22.1
19.3
-1.9
18.2
25.7
25.5
34.7
29.3
47.5
1.8

May-15

Revenues
27.9
21.2
18.5
25.8
4.7
16.3
16.7
23.1
15.7
21.3
15.6
8.7
11.0
19.5
20.2
37.9
28.0
25.1
10.1

Cardiac
Gastro
Intestinal
Vitamins /
Minerals /
Anti Diabetic

Ajanta Pharma
Alembic Pharma
Apollo Hospitals
Aurobindo Pharma
Biocon
Cadila Healthcare
Cipla
Divi's Labs
Dr Reddy's Labs
Glenmark Pharma
Indoco Remedies
Ipca laboratories
Jubilant
Lupin
Natco Pharma
Sun Pharma
Syngene Int
Torrent Pharma
Unichem Laboratories

Apr-15

Financial CAGR in FY11-16

Profit
18.0
-13.9
43.8
17.1
-17.5
17.3
18.1
12.0
10.6
24.7
47.9
74.3
43.9
21.2
20.9
23.3
29.5
-20.2
34.1

Exhibit 14: Leading brands in Indian formulation market (| crore)


Brand

Company

Therapy

FY16

FY15

Gr.(%)

Augmentin

Glaxosmithkline PharmaceAmoxycillin; Clavulanic Acid

API

Anti-Infectives

317.5

319.0

-0.5

Corex

Pfizer Ltd

Respiratory

310.9

228.6

36.0

Chlorpheniramine; Codeine

Spasmo ProxyvWockhardt Ltd

Dicyclomine; Paracetamol

GI

309.3

178.2

73.5

Lantus

Sanofi India Ltd.

Glargine

Anti Diabetic

273.0

220.8

23.6

Galvus Met

Novartis India Ltd

Vildagliptin; Metformin

Anti Diabetic

272.1

187.5

45.1

Clavam

Alkem Laboratories Ltd.

Amoxycillin; Clavulanic Acid

Anti-Infectives

239.9

225.4

6.4

Becosules

Pfizer Ltd

Vitamin B Complex

Vitamins

228.6

243.8

-6.2

Volini

Ranbaxy Laboratories Ltd Diclofenac

Pain

217.0

212.1

2.3

Foracort

Cipla Ltd.

Respiratory

196.1

169.1

16.0

Synflorix

Glaxosmithkline PharmaceAll Other Vaccines

Vaccines

195.1

151.9

28.5

Formoteral; Budesonide

Source: AIOCD data base, ICICIdirect.com Research

Source: Company, icicidirect.com

ICICI Securities Ltd. | Retail Equity Research

Page 5

Exhibit 15: Domestic performance (primary-reported by companies) ICICIdirect.com coverage companies quarter wise
45
38

40

34

35

27

30

(%)

25

21

20

17

15

15

10 10 11

10

16

13

14

17

16

13

11

23

19

19

10
6
2

11

15
11

19

15

17

13

12

0
Ajanta
Pharma

-5

Alembic
Pharma

Biocon

0
Cipla

Cadila

Dr Reddy's
Q1FY16

Glenmark

Q2FY16

Indoco

Q3FY16

Ipca Labs

Lupin

-1
Torrent
Pharma

Sun Pharma

Q4FY16

Unichem
Labs

Source: Company, ICICIdirect.com Research


Exhibit 16: Domestic performance (secondary market) ICICIdirect.com coverage companies
35

18

(%)

20

10

14

14
10

10

17 17

15
7

22

19

18

16

15

10

23 24
15

Ajanta
Pharma

Alembic
Pharma

13

2
Cadila

Cipla

19
14

17

Dr Reddy's
Q1FY16

Q2FY16

Glenmark
Q3FY16

4
0
Indoco
-2

19

18

15

12

12
9

Biocon

18

15

0
-5

28

27

25

25

15

32

30

30

Ipca Labs

Lupin

Sun Pharma

Torrent
Pharma

13
5

Unichem
Labs

Q4FY16

Source: AIOCD data base, ICICIdirect.com Research

ICICI Securities Ltd. | Retail Equity Research

Page 6

Stock performance

Apollo Hospitals

Capex cycle on; expansion of pharmacy business affects margins

240
220
200
180
160
140

CNX Pharma

Apollo Hospitals

Mar-16

Jan-16

Nov-15

Sep-15

Jul-15

May-15

Mar-15

120
100
80
60

Nifty

Key Financials
(| Crore)
Revenues
EBITDA
Adjusted PAT
Adj. EPS (|)

FY15
5178.5
734.7
326.5
23.7

FY16P
6085.6
782.3
301.9
22.2

FY17E
6956.2
1063.0
482.6
34.7

FY18E
7974.5
1299.1
679.2
48.8

FY15
0.6
55.0
27.4
28.6
5.9
10.4
9.9

FY16E
0.8
56.4
26.6
26.8
5.4
8.9
8.2

FY17E
0.7
38.7
19.3
19.7
4.9
12.5
10.8

FY18E
0.6
27.5
15.4
16.2
4.2
15.3
13.3

Key Ratios
Debt / Equity
PE (x)
EV to EBITDA (x)
Target EV/EBITDA (x)
Price to book (x)
RoNW (%)
RoCE (%)

FY16 Highlights
Revenues grew 17.5% YoY mainly due to consolidation of Hetero
Pharmacy, Nova Speciality Hospital and Guwahati Hospital. The
hospital segment grew 9.4% while the pharmacy business grew
31% YoY
Strong growth in the low margin pharmacy business led to
contraction in EBITDA margin by 133 bps YoY to 12.9% in FY16.
The pharmacy business margins were 3.6% while healthcare
services margins were 21.3%
Total 1,725 beds in 11 locations were commissioned in the last
36 months Vanagaram 260, Jayanagar 140, Trichy 200, Nashik
120, Women and Child OMR 60, Indore 120, Nellore 190,
Perungudi 150, women & child SMR 50, Vizag new 245,
Malleswaram 190. Chennai cluster revenues grew 11% YoY in
FY16 to | 1378 crore and Hyderabad cluster revenues grew 8%
in FY16 to | 535.4 crore
Revenues from new hospitals grew to | 318.7 crore in FY16 from
| 176.7 crore in FY15. FY13 Hospitals Vanagaram & Jayanagar
reported an EBITDA of | 19.5 crore in FY 16 compared to | 6.8
crore in FY15
Hospitals in Vizag and Malleswaram were commercialised in
Q4FY16 with ~50% occupancy rate
Currently, 15% of business can be attributed to international
patients
The company added 251 pharmacy stores and closed 51 stores
in FY16, taking the total number of pharmacy stores to 2326
The company entered into an agreement with Patanjali to market
its products through Apollos stores
What to Watch
Apollo plans to add 545 beds in Navi Mumbai (480 beds) and
Indore (65 beds). The Navi Mumbai hospital is expected to be
commissioned by Q2FY17 (150-200 beds initially)
The company plans to add another 500 beds in FY19 South
Chennai 200, South Mumbai 300
Total capex estimated for this expansion plan is | 1520.4 crore.
Of this, investment of | 584.1 crore has already been made.
Balance will be invested through a mix of internal accruals, debt
Apollo is planning expansion of its international business in
South East Asia along with Africa and the Middle East. The
company expects it to improve to 20-25%, going forward
Apollo expects overall EBITDA margins to reach 20% level in five
years from 13.7% in FY16
The company gave tax rate guidance of 20-21% for FY17, FY18
Our View
With more and more players getting listed in healthcare space, we
believe scrutiny for margin improvement and improvement in return
ratios may intensify. Newly commissioned hospitals have achieved the
BE level fairly ahead of our expectations. Focus now is likely to shift to
operational gauges for different cluster hospitals as the current phase of
the capex cycle nears the end. On the pharmacy front, margins showed a
substantial improvement in the last few quarters. We value the stock on
an SOTP basis by valuing the healthcare business at 15x FY18E
EV/EBITDA and pharmacy business at 1.5x FY18E EV/sales. Our SOTP
target price is | 1420. We continue to monitor progress on margins and
return ratios.

ICICI Securities Ltd. | Retail Equity Research

Page 7

Ajanta Pharma

Stock Performance

Visibility intact amid near term challenges

200
180
160
140
120
100
80

CNX Pharma

Ajanta Pharma

Mar-16

Jan-16

Nov-15

Sep-15

Jul-15

May-15

Mar-15

60

Nifty

Key Financials
(|crore)
Revenues

FY15

FY16P

FY17E

FY18E

1480.6

1729.4

2011.0

2368.9

EBITDA

505.2

582.3

682.2

791.8

Net Profit

309.9

403.3

462.5

561.5

36.0

45.7

52.4

63.6

FY15

FY16E

FY17E

FY18E

EPS (|)

Key Ratios
Debt / Equity
PE (x)
M.Cap/ Revenues (x)

0.1

0.1

0.0

0.0

42.7

32.8

28.6

23.6

8.9

7.7

6.6

5.6

EV to EBITDA (x)

26.0

22.7

19.3

16.3

Price to book (x)

15.7

11.3

8.6

6.7

RoNW (%)

37.8

34.4

30.0

28.2

RoCE (%)

50.3

43.7

37.9

35.6

FY16 highlights
Revenues for FY16 grew 16.8% YoY to | 1729 crore mainly due
to the strong growth in the African tender business and domestic
cardiology segment
The export business grew 19% YoY to | 1162 crore due to strong
growth in the African tender business. African tender business
grew 51.8% to | 413 crore. Total African & Asian business grew
29% and 7% to | 682 crore and | 469.5 crore, respectively
The domestic branded business grew 18.9% to | 497 crore
mainly due to strong growth in the cardiology segment, which
was partially offset by slow growth in the dermatology segment
on account of increased competition from the Melacare brand
The domestic institutional business declined to | 35 crore in FY16
from | 61 crore in FY15
Global field force strength has gone up from 572 to 650 in FY16
Total 26 ANDAs have been filed in the US market, out of which
five have been approved. Sales in FY16 accounted for ~US$2
million
What to watch
Guided for 33-35% EBITDA margins for FY17. In the domestic
market, it expects 18-20% YoY growth while in exports it expects
mid-teen growth
The company expects ~US$10 million revenues from US sales in
FY17 and US$20 million for FY18
It plans to file eight to 12 ANDAs every year
R&D guidance for FY17 - 7% of sales
Guided for 25-26% of tax for FY17 and 24-25% for FY18
Guided for capex of ~| 475 crore for FY17. This includes
allocation towards the development of the Guwahati plant (| 300
crore), new corporate office, capitalisation of R&D (| 100 crore for
next two years) and maintenance capex (| 50-60 crore annually)
Validation batches from the Dahej plant have been started. The
company expects to start US filing from H1FY17. It expects to
commercialise the Dahej facility and Phase I of the Guwahati
facility from Q1FY18. Guwahati phase II is expected to start from
Q1FY19
Our view
The company is entering the stretched phase of capex across two to
three years to bolster the domestic business and exports franchise,
especially the US. We believe this is a calculated move as Ajanta
prepares to scale up in the backdrop of 1) challenges in the domestic
derma space 2) currency translation issues in emerging markets and 3)
slower-than-expected off-take in the US. With a strong balance sheet and
high return ratios, we believe the time is ripe for the company to enter
the capex cycle, the benefit of which is likely to pan out beyond FY18.
We have ascribed a target price of | 1780 based on 28x FY18E EPS of
| 63.6.
Exhibit 17: Notable Para IV Filings
Brand Name

Indicator

Generic Name

NDA holder

Abilify

Depression

apriprazole

Otsuka Pharma

Filing Date
17-Mar-15
[

Source: Bloomberg, ICICIdirect.com Research

ICICI Securities Ltd. | Retail Equity Research

Page 8

Alembic Pharma

Stock Performance

gAbilify windfall boosts FY16 numbers; sharp R&D spike to impact near
term profitability

CNX Pharma

Alembic Pharma

Mar-16

Jan-16

Nov-15

Sep-15

Jul-15

May-15

Mar-15

240
220
200
180
160
140
120
100
80
60

Nifty

Key Financials
(|crore)
Revenues
EBITDA
Net Profit
EPS (|)

FY15
2056.2
404.6
284.3
15.1

FY16P
3140.4
1006.0
719.4
38.2

FY17E
3227.1
536.6
369.7
19.6

FY18E
3802.7
746.4
533.1
28.3

FY15
0.3
36.2
41.1
32.2
33.7
32.1
30.7

FY16P
0.1
14.3
16.2
12.6
78.5
51.5
58.0

FY17E
0.1
27.9
31.6
23.9
34.8
22.3
24.8

FY18E
0.1
19.3
21.9
17.3
40.1
26.2
29.7

Key Ratios
Debt / Equity
PE (x)
Target PE (x)
EV to EBITDA (x)
ROIC (%)
RoNW (%)
RoCE (%)

FY16 highlights
Alembics revenues grew 52.7% YoY to | 3140 crore in FY16 on
account of gAbilify launch in the US by its partner under shared
exclusivity. gAbilify launch and a better product mix in the
domestic market caused an EBITDA margin expansion of 1230
bps to 32% in FY16
The company received four Form 483 observations from the
USFDA in March 2016 for its Panelav facility. The same facility
was also inspected by the agency last year without any
observations. Post the observations, the company received
ANDA approval from USFDA to be sold from the facility
APLs cumulative ANDAs were at 76. In FY16, it filed eight
ANDAs and received nine approvals in FY16. The company filed
nine DMFs in the US market in FY16 taking the count to 81
The company had launched 11 products under its own label in
FY16
APL has added ~1400 MRs in the past two years in the domestic
market to widen its focus on the specialty segment by
introducing more divisions within segments taking the total MR
strength to ~5000
What to watch
Guided for | 450 crore (14-15% of sales) of R&D spending in
FY17
Guided for higher than | 300 crore capex in FY17. Total | 80-100
crore capex for its JV with Orbicular for dermatology portfolio.
Under the JV, It shortlisted ~40 products for future development.
Total market size of these opportunities is ~US$5 billion
The company expects six to nine ANDA approvals in FY17
The Sikkim plant became fully operational during Q4FY16. It is
expected to reach full capacity utilisation in FY17
Reiterated tax rate guidance of ~20% for FY17
Our view
With the announcement of aggressive R&D and capex plans, the
management has signalled the strategy for the next five to six years,
especially on the US front. This includes a foray into niche areas like
oncology, injectables, derma, etc. This, we believe, is fraught with a new
set of challenges, the benefits of which are most likely to be back-loaded.
The company is now at a new inflection point as it prepares to do away
with one-off finite opportunities in the US. The immediate cash-burn is
likely to weigh on sentiments in the near term. Accordingly, we have
reduced our FY17E, FY18E EPS estimates by 31% and 21%, respectively.
Our target price is | 620 based on 22x FY18E EPS of | 28.3.

ICICI Securities Ltd. | Retail Equity Research

Page 9

Exhibit 18: Notable Para IV Filings


Brand Name

Indicator

Generic Name

NDA holder

Abilify

Depression

apriprazole

Otsuka Pharma

Filing Date
9-May-14

Brilinta

Cardiovascular

Ticagrelor

AstraZeneca

30-Oct-15

Lyrica

diabetic peripheral neuroppregabalin

Pfizer

7-Dec-11

Multaq

prevention of cardiovascudronedarone hydrochloride

Sanofi

4-Apr-14

Staxyn

erectile dysfunction

vardenafil hydrochloride

Bayer

18-Sep-15

Uloric

febuxostat

hyperuricemia

Takeda

19-Nov-13

Viibryd

major depressive disorde Vilazodone Hydrochloride

Forest Laboratories

30-Mar-15

Benicar

hypertension

Daiichi Sankyo

olmesartan medoxomil

1-Apr-16
[

Source: Bloomberg, ICICIdirect.com Research

Aurobindo Pharma

Stock Performance

Highest ever approvals in FY16; robust product basket bodes well for future

150
140
130
120
110
100
90
80

CNX Pharma

Aurobindo Pharma

Mar-16

Jan-16

Nov-15

Sep-15

Jul-15

May-15

Mar-15

70

Nifty

Key Financials
(| Crore)
Revenues
EBITDA
Net Profit
Adjusted PAT
EPS (|)
Adjusted EPS (|)

FY15
FY16P
FY17E
FY18E
12120.5 13831.2 15543.9 17652.7
2563.6 3140.7 3524.3 4109.8
1575.8 1915.6 2200.6 2627.8
1635.4 1981.6 2200.6 2627.8
27.1
32.8
37.7
45.1
28.1
33.9
37.7
45.1

Key Ratios
Debt / Equity
PE (x)
Target PE (x)
EV to EBITDA (x)
Price to book (x)
RoNW (%)
RoCE (%)

FY15
0.9
27.5
36.6
30.7
8.4
31.7
23.4

FY16E
0.5
22.7
30.2
24.8
6.2
28.1
25.0

FY17E
0.4
19.7
26.3
22.0
4.8
24.3
24.6

FY18E
0.2
16.5
21.9
18.5
3.8
22.9
26.4

ICICI Securities Ltd. | Retail Equity Research

FY16 Highlights
Revenue growth of 14% was largely driven by strong US sales
on the back of extensive product launches
Received highest ever USFDA annual approvals (49 final USFDA
approvals including 20 injectable approvals and nine tentative
approvals) among all Indian pharma companies
Filed 78 ANDAs with USFDA under injectables segment
(including ophthalmic) of which 29 have received approvals. The
company launched 28 products in the US during FY16
Cumulative ANDA filings were at 398 including 215 final
approvals, 36 tentative approvals and 147 pending approvals
Received EIR for Unit III (January 2016 inspection), Unit VII,
Auronext, Unit XI (API facility) and Unit VIII (API facility). Unit XII
(July 2015 inspection) is pending EIR. Unit IV (September 2014
inspection) is expected to be inspected within the next 12
months.
Auromedics garnered sales of US$36.3 million registering growth
of 98% YoY on account of new product launches
Natrol recorded revenue growth of ~15% in FY16 to US$110
million. Natrols margins are better than the companys
consolidated margins
Actavis portfolio has start generating net profit during the year
Net debt was US$584 million with cash of ~US$127 million
Capex was US$212 million (US$18 million intangible and US$194
million tangible)
What to watch
The company expects Nexium launch in H2FY17. It expects stiff
competition due to a crowded market
Aurobindo plans to start filing oncology and hormonal products
in the US in the next four quarters while injectable filings are
expected to be same as FY16
For the Natrol business, the company guided for 15% YoY
revenue growth with margin expansion
The company is planning an expansion of its injectable capacity
and de-bottlenecking of capacity at unit VII
Guided for high single digit EBITDA margins for Europe in a
couple of years
Guided for 4-4.5% of R&D spending in FY17E
Guided for | 1200 crore of capex in FY17E and | 500 crore in
FY18E

Page 10

Our view
The company continues to thrive in the US, backed by a robust product
pipeline and niche launches. Despite a sharp increase in approvals in
FY16 (49 final approvals, nine tentative approvals), the filing to final
approval gap (147 at present) still bodes well for future US growth. We
expect initial margin pressure on account of Actavis and now Natrol, to
ease further on the back of incremental high margin US launches. With
the USFDA expected to hasten the approval process (90% of approvals
by September 2017) companies like Aurobindo will stand to benefit the
most. We have ascribed a target price of | 990, based on 22x FY18E EPS
of | 45.1.
Exhibit 19: Notable Para IV Filings
Brand Name

Indicator

Generic Name

NDA holder

Filing Date

Acular LS

Ocular Pain

Ketorolactromethamine

Allergan

6-Nov-15

Prevacid

Stomach ulcers

lansoprazole

Salix Pharmaceuticals,

13-Oct-15

Xarelto

Blood Thinner

Rivaroxaban

Takeda Pharma

21-Oct-15

Aloxi

nausea and vomiting

palonosetron hydrochloride

Roche

15-Apr-13

Angiomax

blood clots

bivalirudin

The Medicines Compan

11-Apr-13

Boniva

osteoporosis

biphosphonic acid

Roche

22-Jan-13

Allegra-D

seasonal allergies

fexofenadine hydrochloride

Sanofi-Aventis U.S. LLC

5-Nov-10
[

Source: Bloomberg, ICICIdirect.com Research

Stock Performance

Biocon

180

Event full FY16; biosimilars progress to trigger growth

160

FY16 Highlights
Biocons revenues grew 12.8% to | 3485.4 crore on account of
30% growth in Syngene to | 1068.5 crore
The company raised ~| 550 crore via unlocking of Syngene
(IPO).. Biocon offloaded ~11% stake in the process. Proceeds
from the IPO are expected be used by Biocon for its biosimilar
pipeline
Four of its biosimilar products (Trastuzumab, Pegfilgrastim,
Adalimumab and Insulin Glargine) reached the advanced stage
(Phase III or beyond) of global clinical trials
The company received first biosimilar approval in a developed
market with Japanese approval of Insulin Glargine. Its partner
Fujifilm Pharma expects to commercialise the product in H1FY17.
The company also launched its biosimilar Glargine in emerging
markets while five of its biosimilar products entered late stage
development
Biocon, with its partner Mylan, has announced positive phase III
data for biosimilar of a Roche biological Herceptin (Trastuzumab;
oncology). Global sales of the drug were ~US$6.5 billion in FY16
The company has completed Phase I study for Insulin Tregopil
(insulin) in the US with BMS as its partner
Biocon acquired API and oncology formulation manufacturing
unit of M/s. Acacia Lifesciences Pvt Ltd at Vishakhapatnam
Malaysian facility is in validation stage and is expected to receive
regulatory approvals in near term. The company plans to
commercialise sales of insulin in Malaysia and other emerging
markets in FY17. The Malaysian plant has received local approval
The company is in the process of setting up oral solid dosage
facility for generic formulations and sterile formulations facility

140
120
100
80

CNX Pharma

Biocon

Mar-16

Jan-16

Nov-15

Sep-15

Jul-15

May-15

Mar-15

60

Nifty

Key Financials
(| Crore)
Revenues
EBITDA
Adj. Net Profit
Adj. EPS (|)

FY15
3089.8
695.8
408.4
20.4

FY16P
3485.4
820.0
441.2
22.1

FY17E
4031.8
955.6
565.2
28.3

FY18E
4647.9
1103.4
609.5
30.5

FY15
0.3
32.2
26.6
12.5
10.4
9.6
4.0

FY16E
0.6
14.7
24.7
10.9
9.1
8.7
3.2

FY17E
0.5
23.3
19.2
12.7
10.9
7.3
3.0

FY18E
0.5
21.6
17.8
12.5
11.1
6.0
2.7

Key Ratios
Debt / Equity
PE(x)
Target PE (x)
EV to EBITDA (x)
Price to book (x)
RoNW (%)
RoCE (%)

ICICI Securities Ltd. | Retail Equity Research

Page 11

for biologics business. These plants are being built in Bangalore


SEZ area and are expected to be commissioned in CY17
The company has filed seven ANDAs with the USFDA till the end
of FY16. It has filed gCopaxone (Glatiramer acetate; multiple
sclerosis) 20 mg and 40 mg with the USFDA

What to watch
Biocon is planning US/EU biosimilar filings for Trastuzumab,
Pegfilgrastim, insulin Glargine and Adalimumab in FY17
The management has reiterated its FY19 revenue guidance of
US$1 billion
The company expects higher growth for biosimilars in emerging
markets and branded formulations and mid single digit growth
for small molecules
Progress of the Malaysian insulin plant, which has recently been
commissioned. It expects emerging market sales from this plant
to start from FY17 and expects developed market approval by
FY18
The company plans to spend 18-20% (gross) of biopharma sales
on R&D expenditure for FY17
Biocon is planning standalone capex of | 200-225 crore for FY17.
This includes maintenance capex along with additional capex
required for commissioning the two new facilities in Bangalore
Our view
Syngene continues to maintain growth momentum. However, the
positive surprise was biopharma growth on the back of biosimilar
launches in emerging markets. This, along with the Japanese Glargine
approval and proposed filing in other markets bodes well for the future
as the company expects higher contribution from biosimilars, going
forward. On the other hand, prolonged restructuring, pricing pressure
and capacity constraints continue to impact small molecules growth.
Given the different fortunes for different segments, we continue to adopt
SOTP methodology for valuation. Our SOTP target price is | 545.
Cadila Healthcare

Stock Performance

Moraiya resolution, site transfer momentum to be in focus

200
180
160
140
120
100
80

CNX Pharma

Cadila Healthcare

Jan-16

Nov-15

Sep-15

Jul-15

May-15

Mar-15

60

Nifty

Key Financials
(|crore)
Revenues

FY15

FY16P

FY17E

FY18E

8635.8

9844.0

10921.5

13140.0

EBITDA

1740.2

2389.3

2393.0

3048.6

Net Profit

1146.4

1530.8

1586.0

2105.5

11.2

15.0

15.5

20.6

EPS (|)

ICICI Securities Ltd. | Retail Equity Research

FY16 Highlights
Cadila revenues grew 14% in FY16 to | 9844 crore on account of
19% growth in US sales. EBITDA margins grew 412 bps YoY to
24.3%
The company received a warning letter from the USFDA for its
Moraiya formulation facility and Ahmedabad API facility (Zyfine).
~60% of its US revenues (25% of overall revenues) are from
Moraiya facility
On the other hand, four formulation facilities, viz. oral solid
dosage facility, oncological injectable facility (Alidac),
transdermal facility (all in Ahmedabad SEZ) and oral solid dosage
facility at Baddi received the establishment inspection (EIR) from
the USFDA
The company successfully completed site transfer of five
products from Moraiya to Baddi for the US market in FY16, taking
the cumulative number of such site transfer products to 12
FY16 capex was ~| 950 crore. This includes acquisition of select
animal healthcare brands, the manufacturing operations in India
from Zoetis and acquisition of Actibile (GI), the brand from Albert
David

Page 12

Key Ratios
Debt / Equity
PE (x)

FY15

FY16E

FY17E

0.6

0.4

0.2

FY18E
0.1

28.5

21.4

20.7

15.6

Target PE (x)

34.8

26.1

25.2

19.0

EV to EBITDA (x)

19.9

14.2

14.1

10.8

Price to book (x)

7.7

6.1

5.1

4.1

RoNW (%)

27.0

28.6

24.4

26.3

RoCE (%)

20.7

27.9

24.6

29.5

In FY16, the company filed 30 ANDAs with the USFDA taking


cumulative ANDA filings to 269 and received approval for 10
ANDAs (including one tentative approval)
The company launched 40 products in domestic formulations
including line extensions in India during FY16, of which 10 were
for the first time in India
In LatAm, the company launched two new products in Brazil and
two in Mexico in FY16
In Europe, it launched three new products in France and four
new products in Spain. The company filed 14 new product
dossiers in FY16, taking its cumulative filings to 205 and received
approval for 11 new products, taking its cumulative approvals to
164 for the European market
The company launched eight new products in the focused
markets of Asia-Pacific, Africa and Middle East during FY16. This
included the launch of first biosimilar in the emerging markets
On the biosimilars front, the company completed Phase III clinical
trials for one of the mAbs and received regulatory approval from
the DCGI to conduct Phase III clinical trials for one more product.
On the novel biologics front, it initiated the next phase of clinical
trials for Rabimabs (anti-rabies)
R&D spend for FY16 was 7.7% of sales, of which 75% was
earmarked for ANDA development
On the biosimilars front, the company completed Phase III clinical
trials for one of the mAbs and received regulatory approval from
the DCGI to conduct phase III clinical trials for second product.
On the novel biologics front, it initiated the next phase of clinical
trials for Rabimabs (anti-rabies)

What to watch
Cadila plans to complete remediation process of Moraiya facility
by May 2016 and request re-audit of the facility by USFDA
The company expects to receive 20 approvals during FY17
It expects a tax rate of 20% for FY17 and R&D at 7-8% of sales
Cadila expects its domestic growth in FY17 to be better than
FY16 growth (11% YoY) and JVs sales to remain flat in FY17
EBITDA margins are expected to be ~22% for FY17
Our view
Despite the warning letter at Moraiya, we believe the US would remain a
key driver on the back of expected launch of gAsacol in Q2FY17, more
than 50% pending approvals from other facilities and initiated site
transfers from Moraiya. However, the transfer arrangement is likely to
delay its future launches while some key competitive opportunities may
be lost in the process. Similarly, the non-generic space is yet to achieve
critical mass. We have ascribed a target price of | 390 based on
19xFY18E (earlier 20x) EPS of | 20.6.

ICICI Securities Ltd. | Retail Equity Research

Page 13

Exhibit 20: Notable Para IV Filings


Brand Name

Indicator

Generic Name

NDA holder

Exelon

dementia

rivastigmine

Novartis

Filing Date
27-Aug-13

Daliresp

Chronic Obstructive PulmRoflumilast

AstraZeneca

15-May-15

Nexium

gastroesophegal reflux di esomeprazole magnesium

AZ

12-Aug-13

Abilify

Depression

aripiprazole

Otsuka Pharma

30-May-08

LIVALO

high cholesterol

Pitavastatin Calcium

Kowa Pharma

17-Apr-14

Optivar

seasonal allergic rhinitis azelastine hydrochloride

Meda Pharmaceuticals

22-Mar-10

Strattera

attention-deficit hyperact atomoxetine hydrochloride

Eli Lilly and Co.

27-Oct-10
[

Source: Bloomberg, ICICIdirect.com Research


[

Stock Performance

Cipla

gNexium supports FY16; margins enigma to weigh in near term

190
170
150
130
110
90
70

CNX Pharma

Cipla

Mar-16

Jan-16

Nov-15

Sep-15

Jul-15

May-15

Mar-15

50

Nifty

Key Financials
(|crore)

FY15

FY16P

FY17E

FY18E

11345.4

13678.3

16129.4

18477.9

EBITDA

2161.7

2501.1

2761.6

3349.2

Adjusted PAT

1180.8

1505.9

1600.7

2101.3

14.7

18.8

19.9

26.2

FY15

FY16E

FY17E

FY18E

0.2

0.4

0.3

0.2

PE (x)

31.8

24.9

23.5

17.9

Target PE (x)

32.0

25.1

23.6

18.0

EV to EBITDA (x)

17.7

16.6

14.8

11.8

Revenues

Adj. EPS (|)

Key Ratios
Debt / Equity

Price to book (x)

3.5

3.2

2.8

2.5

RoNW (%)

10.9

12.7

12.1

14.1

RoCE (%)

13.8

12.1

13.1

16.0

ICICI Securities Ltd. | Retail Equity Research

FY16 highlights
Revenues grew 20.6% to | 13678.3 crore mainly on account of
gNexium supply to Teva under exclusivity
Cipla acquired InvaGen and Exelan Pharma in the US for US$550
million. The combined revenue of these companies was
~US$230 million in CY15. Also, Ciplas management has
indicated that the issued USFDA 483 observations at InvaGens
plant had been resolved. Post acquisition, contribution of US
sales to overall revenues was ~20%
Ciplas Indore plant received nine 483 observations from USFDA
In FY16, the company filed for seven products in the US, 19 in
Europe and over 700 in international markets
The company has over 200 formulation development projects
under way, of which top 50 projects cover an addressable market
of US$30 billion, based on innovative sales. Of these, the US
accounts for 26 projects. Inhalation and injectable delivery forms
account for 25 of the 50 top projects
The impact of the DPCO and FDC ban in FY16 on the domestic
portfolio was 2-3% of sales
The companys tender business in South Africa grew 60% YoY in
FY16. Currently, it has ~5% market share in the South African
private market and is the third largest generics player in the
market
The company accelerated execution plan for in-house biologics
clinical trial for Bevacizumab (angiogenesis inhibitor) and proofof-concept (POC) for two or three other products
The company has filed 168 cumulative ANDAs with the USFDA,
of which 90 have been approved
What to watch
Guided for mid-teens revenue growth and EBITDA growth of 1520% on its base business. Base EBITDA margins are expected to
be 16-18%, going forward
The company plans to launch 15-17 products in the US (including
five to seven from InvaGen) and file 20-25 ANDAs in FY17,
including filings in respiratory and oncology segments
In FY16, the company executed six in-licensing deals in
oncology, respiratory and dermatology segments in the domestic
market. It has also, initiated five incremental innovation projects,
of which three would be commercialised in FY17
The company gave R&D guidance of 8% of sales for FY17. R&D
spends for FY16 was 6.5% of sales

Page 14

The company is planning clinical trials and filing for its metered
dose inhaler (MDI) device in the US in FY17
The companys capex for FY16 was ~8% of sales. It guided for
similar percentage of capex for FY17

Our view
The key takeaway from the management commentary post FY16
numbers was exceptionally conservative margin guidance (16-18% for
base business for the next three years). This is despite factoring in
respiratory and other interesting launches in the developed markets.
Frequent restructuring indicates that the management is still some
distance away from a sustainable business model. In this backdrop, the
Street is likely to focus only on the profitability aspect. Our target price is
| 470 based on 18x (earlier 21x) FY18E EPS of | 26.2.
Exhibit 21: Notable Para IV Filings
Brand Name

Indicator

Generic Name

NDA holder

Reyataz

HIV

Atazanavir

Bristol Myers Squibb

Filing Date
19-Feb-16

Emtriva

HIV

emtricitabine

Gilead Sciences

20-Aug-12

Pataday

allergic or inflammatory eolopatadine hydrocholric solution Alcon Research

29-Jan-14

Prezista

HIV

darunavir

Tibotec Inc.

13-Aug-14

Sustiva

HIV

rivastigmine tartrate

Merck

27-Jun-13
[

Source: Bloomberg, ICICIdirect.com Research

Divis Laboratories

Stock Performance

Lower guidance due to delay in expansion

200
180
160
140
120
100
80

CNX Pharma

Divi's Labs

Mar-16

Jan-16

Nov-15

Sep-15

Jul-15

May-15

Mar-15

60

Nifty

Key Financials
(|crore)

FY15

FY16P

FY17E

FY18E

Revenues

3114.9

3721.3

4292.5

5015.5

EBITDA

1165.2

1396.1

1588.2

1830.6

851.5

1107.7

1215.0

1389.8

32.1

41.7

45.8

52.4

FY15

FY16E

FY17E

FY18E

0.0

0.0

0.0

0.0

Adj. Net Profit


Adjusted EPS (|)

Key Ratios
Debt / Equity
PE (x)

32.5

25.0

22.8

19.9

Target PE (x)

39.3

30.2

27.5

24.1

EV to EBITDA (x)

23.1

19.2

16.9

14.4

Price to book (x)

7.9

6.5

5.4

4.5

RoNW (%)

24.4

25.8

23.6

22.6

RoCE (%)

29.4

30.6

29.1

28.4

ICICI Securities Ltd. | Retail Equity Research

FY16 highlights
Revenues grew 19.5% to | 3721.3 crore while EBITDA margins
stayed muted at 37.5%.
Generic: CS sales ratio for FY16 was 55:45
Carotenoids sales for FY16 were | 193 crore
Total | 252 crore was capitalised in FY16 and CWIP as on March
2016 is | 264 crore. Current capacity utilisation is ~87% across
plants
The company had forex gains of | 24 crore in FY16
Vizag facility received EIR post USFDA inspections that happened
in February, 2016. Hyderabad facility was last inspected in 2015
What to watch
The company altered revenue guidance for FY17 to 14-15%
(from 15-20%)
Capex for Kakinada and Vizag (greenfield) facilities is likely to be
~| 900 crore to be spread between FY17 and FY18. The capex
for the facilities has been delayed by two months. The funding
for the capex will be mainly through internal accruals
Our view
The management has altered the revenue growth guidance from 15-20%
to 14-15% as the Kakinada expansion has been delayed. However, once
materialisation of | 750 crore capex happens, which the company
intends to undertake soon, sales growth for FY18 onwards can go back
to the higher trajectory. With the kind of FCF generation rate, the
proposed capex is not going to affect leverage. The company remains in
a sweet spot both in the generics and custom synthesis space. It remains
a preferred player for generic supplies for many generic opportunities
arising from the impending patent cliff. We have valued the stock at
| 1260 based on 24x FY18E EPS of | 52.4.

Page 15

Dr Reddys Laboratories

Stock Performance

Near term concerns persist but long term visibility intact

200
180
160
140
120
100
80

CNX Pharma

Dr Reddy's

Mar-16

Jan-16

Nov-15

Sep-15

Jul-15

May-15

Mar-15

60

Nifty

Key Financials
(|crore)

FY15

Revenues

FY16P

FY17E

FY18E

14818.9 15470.9 16608.5 18911.7

EBITDA

3482.7

3982.5

3945.9

4739.3

Adjusted PAT

2198.6

2422.2

2372.8

2964.6

EPS (Adjusted)

129.0

142.1

139.2

174.0

FY15

FY16E

FY17E

FY18E

0.4

0.3

0.2

0.1

23.7

26.3

22.0

17.6

Key Ratios
Debt / Equity
PE (x)
Target PE (x)

27.0

24.5

25.0

20.0

EV to EBITDA (x)

15.0

13.1

12.8

10.2

Price to book (x)

5.3

4.1

3.6

3.0

RoNW (%)

22.3

18.9

16.1

16.8

RoCE (%)

16.7

15.1

15.1

18.3

FY16 Highlights
Revenues grew just 4.4% to | 15470.9 crore. The FY16
performance was largely impacted by one-offs on account of
remedial expanses, Venezuela adjustment and volatility in entire
RoW and European businesses
Dr Reddys received a warning letter from the USFDA for three of
its manufacturing facilities. These include two API facilities at
Srikakulam, Andhra Pradesh and Miryalaguda, Telangana and
one oncology formulation facility at Duvvada, Vishakhapatnam.
Out of these three facilities, the Srikakulam API facility is the
major API plant for DRL
The company has cumulative filings of 234 ANDAs (52 Para IV
filings and 18 FTFs) and three NDAs with the USFDA of which it
has received approval for 155 ANDAs
The company has successfully executed site transfer of four to
five products. One or two products have been approved for site
transfer while a few others have been submitted for approval
It launched Zembrace SymTouch (Sumatriptan Succinate)
injection for the acute treatment of migraines in adults in the US.
The company is planning to launch of Sernivo (betamethasone
dipropionate) spray for the treatment of mild to moderate plaque
psoriasis in adults. It has also received USFDA approval for Aloxi
505 b (2) injection (anti-nausea drug) in March 2016
Dr Reddys entered into a license agreement with XenoPort for
exclusive US rights for XP23829 on milestone and double digit
royalty basis. The company plans to develop XP23829 as a
potential treatment for moderate-to-severe chronic plaque
psoriasis and may potentially develop XP23829 for relapsing
forms of multiple sclerosis (MS). Dr Reddys will pay an upfront
fee of US$50 million to XenoPort and up to US$440 million based
on milestones. In September 2015, XenoPort announced results
of a Phase II clinical trial of XP23829 as a potential treatment for
moderate-to-severe chronic plaque-type psoriasis
The domestic business had negligible impact from the
government ban of certain FDC products
The company completed integration of UCB portfolio. The UCB
portfolio performance was in line with company expectations.
Normalising for contribution from the UCB portfolio, growth of
the base business during the year is healthy
R&D expenditure was | 1783 crore (11.5% of sales) for FY16
What to watch
The company expects its gross margins to remain muted in
H1FY17 on account of realisation pressure in the US owing to
customer consolidation
The company has submitted its first remedial update to USFDA
on January 28, followed by a second one on March 30 2016. It
expects most of its commitments to the USFDA to be over by the
end of Q1FY17. Post this it will request USFDA for reinspection.
The company expects USFDA approvals to peak up from H2FY17
Dr Reddys expects its share in gNexium (GI) market to improve,
going ahead. It expects to get gGleevec (oncology) approval in
FY17
The company gave a capex guidance of | 1200 crore for FY17
and FY18 each, to build new facilities for injectables, topicals and
biosimilars

ICICI Securities Ltd. | Retail Equity Research

Page 16

In FY17 and FY18, the company expects 40-45% of additional


revenues from Injectable business, ~40% from oral solids, 1520% from derma patches and creams for the US market
The company is in the process of price registration for Reditux
(Rituximab) in Russia
The company expects its R&D spending to increase to 12% (from
11.5% in FY16) on account of proprietary product launches.

Our view
The FY16 performance was largely impacted by one-offs on account of
remedial expanses, Venezuela adjustment and volatility in entire RoW
and European businesses. We expect US revenues to normalise from
H2FY17 either by successful resolution of warning letter or site transfers.
Some interesting launches are also expected from the proprietary
products space. India is showing promising growth as well. We expect
an improvement in business mix, going ahead, as the contribution from
margin accretive US + India business to improve to 68.6% in FY18E from
56% in FY15. Our target price is | 3480 based on 20x FY18E EPS of
| 174.0.
Exhibit 22: Notable Para IV Filings
Brand Name

Indicator

Angiomax

anticoagulant for patients bivalirudin

Generic Name

Boniva

osteoporosis

NDA holder

Filing Date

Medicis Pharma

28-Apr-11

ibandronic acid; ibandronate sodi Hoffmann-La Roche Inc.

28-Oct-10

Toviaz

Urotherapy

Fesoterodine

Pfizer

Copaxone

multiple sclerosis

glatiramer acetate

Teva Pharma

Dexilant

erosive esophagitis, hear dexlansoprazole

Takeda Pharma

31-Mar-11

Diprivan

delirium, agitation

Fresenius Kabi

25-May-13

Effient

acute coronary syndromeprasugrel hydrochloride

Eli Lilly

12-Mar-14
19-Jun-14

prpofol

Folotyn

Lymphoma

Pralatrexate

Allos Therapeutics

Gleevec

leukemia

imatinib mesylate

Novartis

Intermezzo

insomnia

zolpidem tartrate

Purdue Pharma

Ixempra

breast cancer

epothilone

Bristol-Myers Squibb

Jevtana Kit

prostate cancer

Cabazitaxel

Sanofi-Aventis

Kuvan

Phenylketonuria

Sapropterin Dihydrochloride

Mozobil

non-Hodgkin's lymphoma plerixafor

8-Nov-15
11-Sep-14

6-Feb-14
2-Apr-13
21-Dec-12
6-Apr-15

Biomarin Pharma

17-Nov-14

Sanofi

29-Aug-13

Mucinex

bronchial congestion

Nexium

treatment of acid reflux] esomeprazole sodium

pseudoephedrine hydrochloride Reckitt Benckiser Inc.


AstraZeneca AB

Pristiq

depression

Pfizer

Reclast

osteoporosis and Paget's zolendronic acid

Novartis Pharma

20-Feb-13

Treanda

chronic lymphocytic leukebendamustine

Cephalon Inc.

20-Dec-13

desvenlafaxine

26-Jun-15
17-Jan-08
4-Jun-13

Uloric

febuxostat

hyperuricemia

Takeda

30-Oct-13

Velcade

cancer

bortezomib

Millennium

25-Jun-15

Copaxone

Multiple Sclerosis

Glatiramer

Teva Pharma

8-Apr-15
[

Source: Bloomberg, ICICIdirect.com Research

ICICI Securities Ltd. | Retail Equity Research

Page 17

Glenmark Pharma

Stock Performance

Product launches across geographies spur growth

200
180
160
140
120
100
80

CNX Pharma

Glenmark Pharma

Mar-16

Jan-16

Nov-15

Sep-15

Jul-15

May-15

Mar-15

60

Nifty

Key Financials
(| Crore)
Revenues
EBITDA
Adjusted PAT
EPS (|)

FY15
6644.8
1225.2
650.9
23.1

FY16P
7746.5
1620.4
906.6
32.2

FY17E
FY18E
8993.0 10442.5
1996.8 2328.9
1166.7 1409.5
41.4
50.1

FY15
1.3
52.5
43.3
22.4
8.1
21.7
13.3

FY16E
0.9
26.9
31.1
17.0
5.7
21.2
16.2

FY17E
0.7
20.9
24.1
13.9
4.5
21.7
18.8

Key Ratios
Debt / Equity
PE (x)
Target PE (x)
EV to EBITDA (x)
Price to book (x)
RoNW (%)
RoCE (%)

FY18E
0.4
17.3
20.0
11.5
3.6
21.0
20.3

FY16 highlights
Revenues grew 16.6% to | 7746.5 crore on account of 18.7%
growth in US sales and 20.6% growth in domestic sales. EBITDA
margins grew 250 bps during FY16 to 20.9%
Domestic business (27% of total revenue) grew 20.6% to | 2109
crore on account of market share gain across therapies and new
product launches
Accumulated ANDAs filings were at 171, including 59 pending
approvals (26 Para IV filings). In FY16, it filed 12 ANDAs with the
USFDA. The company received 24 ANDA approvals (including
five tentative approvals) from USFDA during the year
It launched 24 products in global markets (ex-US) in FY16 of
which 16 were in-licensed
The company concluded the licensing deal with Celon for generic
Seretide Accuhaler in Europe. It obtained semi-exclusive
marketing and distribution rights for the product across 15
European countries, including UK and Germany upon
commercialisation
R&D spend was 9.6% of revenues in FY16 to | 724 crore. Total
| 321 crore of R&D was on innovative products while | 430 crore
was on generic products
The Venezuela business revenues were at | 320 crore for FY16
with net profit at | 75 crore.
What to watch
Guided for 25% revenue growth for FY17. US sales (ex-Zetia) are
expected to grow 15-20% in FY17
Glenmark plans to file more than 25 ANDAs in FY17 and expects
approvals for 10-12 ANDAs
The company gave a capex guidance of US$ 100 million for FY17
and FY18 each.
Guided for 22-25% tax rate for FY17.
Expects US$10-15 million of revenues from Venezuela in FY17
Guided for ~11% of R&D threshold (ex-Zetia) in future
Our View
Going ahead, the US franchisee looks promising with gZetia launch
under exclusivity and strong pipeline of 63 pending approvals (including
26 Para IVs). Domestic formulations continue to maintain higher
trajectory on the back of market share gain in key therapies. Europe and
LatAm continue to buck the trend on the back of new product launches
and strong respiratory traction. The management has guided for ~25%
growth in FY17, including 25% growth in the US business and more than
20% growth in Europe and LatAm. We have ascribed a target price of
| 1000 based on 20x FY18E EPS of | 50.1.

ICICI Securities Ltd. | Retail Equity Research

Page 18

Exhibit 23: Notable Para IV Filings


Brand Name

Indicator

Generic Name

NDA holder

Alimta

Cancer

pemetrexed disodium

Eli Lilly

Filing Date
23-Jan-14

Bystolic

Hypertension

nebivolol

Forest Lab

13-Mar-12

Crestor

high cholesterol

rosuvastatin calcium

Effient

acute coronary syndromeprasugrel hydrochloride

Epiduo

acne

benzoyl peroxide

Galderma Lab

Finacea

rosacea

azelaic acid

Bayer

14-Mar-13

Multaq

prevention of cardiovascudronedarone hydrochloride

Sanofi

6-Mar-14

AstraZeneca Pharmace

26-Apr-10

Eli Lilly

12-Mar-14
6-May-15

Savella

fibromyalgia

milnacipran hydrochloride

Forest Lab

6-Feb-14

Zyvox

Anti-Infective

Linezolid

Symed Labs

4-Nov-15

Velcade

cancer

bortezomib

Millennium

10-Sep-14

Vimpat

epilepsy

lacosamide

UCB Pharma

10-Jul-13

Jevtana Kit

prostate cancer

Cabazitaxel

Sanofi-Aventis

6-Apr-15

Onglyza

type II diabetes

Saxagliptin

Astrazeneca

23-May-14
[

Source: Bloomberg, ICICIdirect.com Research

Indoco Remedies

Stock Performance

Watson offtake, domestic growth tempo key catalysts

200

150

100

CNX Pharma

Indoco Remedies

Mar-16

Jan-16

Nov-15

Sep-15

Jul-15

May-15

Mar-15

50

Nifty

Key Financials
(| Crore)
Revenues
EBITDA
Adjusted PAT
EPS (Adjusted)

FY15
857.0
167.2
82.8
9.0

FY16P
1003.9
174.8
85.8
9.3

FY17E
1197.9
239.7
139.1
15.1

FY18E
1469.9
301.7
187.8
20.4

FY15
0.2
32.6
40.6
16.6
5.2
16.0
16.4

FY16E
0.2
31.5
39.2
16.1
4.6
14.7
13.2

FY17E
0.2
19.4
24.2
11.6
4.1
20.9
19.7

FY18E
0.1
14.4
18.0
9.2
3.5
24.2
24.4

Key Ratios
Debt / Equity
PE (x)
Target PE (x)
EV to EBITDA (x)
Price to book (x)
RoNW (%)
RoCE (%)

ICICI Securities Ltd. | Retail Equity Research

FY16 Highlights
Indoco Remedies revenue grew 17.1% to | 1003.9 crore in FY16
owing to 33% growth in export formulations to | 385.9 crore.
EBITDA margins contracted 210 bps to 17.4%
Domestic formulations (53% of total revenue) grew mere 4.8%
YoY to | 529 crore due to restructuring, inventory adjustment
and the seasonality impact
As per the management, the proposed ban on fixed dose
combinations (FDCs) has a minimal impact (2-3% of domestic
sales) on company sales. Total 9.5-10% of domestic portfolio is
currently under NLEM
The US cumulative ANDA filings were at 34 with 26 pending
approvals (including three tentative approvals). Total 54 products
are under the development pipeline for the US. The company has
launched eight products in the US market (ophthalmics - five,
solid dosage- one and Watson deal- two). Total 14 products have
been filed through Watson
Watson contributed ~US$3 million to the companys revenues in
FY16
Aspen has filed for 22 products with MCC, the regulatory
authority of South Africa. For FY16, Aspen generated sales of
| 20 crore
The company received the Establishment Inspection Report (EIR)
on May 25, 2016 from the USFDA for its sterile and solid dosage
facility (Goa Plant II). Indoco also received the EIR from USFDA
for its Goa Plant I (solid dosages facility) and Goa Plant III
The company has won the tender for Bimatoprost Ophthalmic
Solution in New Zealand. Supplies for the same will commence
soon
It has filed total 70 patents as on date. Out of these, 23 are for
finished dosages and 47 are for API manufacturing processes.
The company has MR strength of 2800 MRs for the domestic
formulations.

Page 19

What to watch
The company expects international sales to grow 30-35% in
FY17. Overall, Indoco expects high teen growth in revenues in
FY17
Guided for ~15% growth in the domestic market for FY17
The company expects US revenues to be ~| 150 crore for FY17
It expects four ANDA approvals per annum. Addressable market
size for these products is ~US$800 million
The company guided for 10 ANDA filings annually
The company expects to launch gVigamox (moxifloxacin; anti
biotic) and gPatanol 0.1% (olopatadine; ophthalmic) in Q2FY17
During FY16, ~| 12.5 crore of R&D was capitalised. The company
is planning an R&D spend of 4.5-5% of sales for FY17
Capex guidance of | 120-125 crore for FY17
Tax rate guidance - 19-20% for FY17
Our View
Going ahead, we expect accelerated USFDA approvals post the EIR for
Goa II. As per the management, domestic formulations are likely to
register decent growth in FY17 after languishing in FY16. Even on the
margins front (sub-par margins vis--vis the peers), the situation is likely
to improve with higher US and domestic traction. Overall, visibility has
improved substantially due to a robust US portfolio (23 pending
approvals). Other deals such as Aspen are likely to provide traction for
ex-US exports. We expect sales, EBITDA and PAT to grow at CAGR of
21%, 31% and 48%, respectively, in FY16P-18E. We have valued the
stock at | 365 i.e. 18x FY18E EPS of | 20.4. Our estimates factor in better
visibility and the track record of the management of timely execution.
Ipca Laboratories

Stock Performance

Multiple headwinds yet to be addressed

190
170
150
130
110
90
70

CNX Pharma

Ipca labs

Mar-16

Jan-16

Nov-15

Sep-15

Jul-15

Mar-15

May-15

50

Nifty

Key Financials
(| crore)
Revenues
EBITDA
Net Profit
EPS (|)
Adj. EPS (|)

FY15
3141.8
529.1
254.2
20.2
19.9

FY16P
2885.0
341.7
93.3
7.4
10.0

FY17E
3245.2
543.2
304.6
24.1
24.1

FY18E
3610.1
657.0
383.8
30.4
30.4

FY15
0.4
21.9
22.6
12.1
2.5
11.4
11.5

FY16E
0.3
59.7
61.5
17.9
2.4
5.5
5.8

FY17E
0.2
18.3
18.8
11.1
2.2
12.0
12.4

FY18E
0.1
14.5
15.0
8.9
1.9
13.3
14.5

Key Ratios
Debt / Equity
PE (x)
Target PE (x)
EV to EBITDA (x)
Price to book (x)
RoNW (%)
RoCE (%)

ICICI Securities Ltd. | Retail Equity Research

FY16 highlights
The company received warning letters for manufacturing units at
Ratlam (Madhya Pradesh), SEZ Indore (Pithampur) and Piparia
(Silvassa). Import alerts were already issued to these plants by
USFDA based on inspections on July 24, 2014, January 23, 2015
and March 25, 2015, respectively
Pithampur facility got cleared by UKMHRA
During the fiscal, the Ratlam facility got clearance from all
regulatory authorities except USFDA. The remedial actions for
the facility are ongoing
Due to warning letters issued by USFDA, Switzerland based
Global Fund, a major contractor for Ipcas anti-malarial tender for
African markets has terminated the contract. According to the
management, the company may lose US$15-20 million (~4% of
revenues) business in FY17 on account of this development
HCQS shipment to the US witnessed a dip in prices during
Q4FY16, in turn, impacting its sales further in the US
Domestic formulation grew a mere 6.9% YoY to | 1207 crore due
to lower anti-malarial offtake
What to watch
Guided for 13-14% (without considering US sales) of revenue
growth with 16-17% of EBITDA margins in FY17. API sales
growth is expected to be 16-17% in FY17
The company expects US$1-2 million of remedial impact on a
quarterly basis till the Ratlam facility is cleared by USFDA
R&D expenses for FY17 are expected to be similar to FY16 in
absolute terms
The company has planned a capex of | 200 crore for FY17, FY18

Page 20

Our View
FY16 has been a wash-out fiscal due to the USFDA import alert,
termination of the global fund tender business, currency fluctuations in
emerging markets and slow growth in the domestic market due to
restructuring. The management expects 13-14% growth in FY17 on the
back of a recovery in the domestic market, strong growth in API, branded
export markets and partial USFDA allowances. Clearance from the Global
Fund tender business and from USFDA will be key events to watch in
FY17. These are, however, sticky issues. The resumption is likely to take
more time than expected. We have ascribed a target of | 455 (15x FY18E
EPS of | 30.4).
Jubilant Life Sciences
Stock Performance

Margin expansion demonstrated in FY16

310
260
210
160
110

CNX Pharma

Jubilant Life Sciences

Mar-16

Jan-16

Nov-15

Sep-15

Jul-15

May-15

Mar-15

60

Nifty

Key Financials
(| crore)
Revenues
EBITDA
Net Profit
EPS (|)
Adjusted EPS (|)

FY15
5826.3
689.3
-57.8
-3.6
-0.6

FY16P
5802.3
1277.8
431.5
27.1
26.0

FY17E
6604.2
1489.0
663.3
41.6
41.6

FY18E
7442.1
1750.4
893.6
56.1
56.1

FY15
2.0
NA
14.4
14.8
2.2
-0.4
5.8

FY16E
1.6
12.8
7.6
7.8
1.9
14.2
12.0

FY17E
1.1
8.3
6.1
6.3
1.6
18.9
15.1

FY18E
0.7
6.2
4.8
5.0
1.3
20.6
17.8

Key Ratios
Debt / Equity
PE (x)
EV to EBITDA (x)
Tar. EV/EBITDA (x)
Price to book (x)
RoNW (%)
RoCE (%)

FY16 Highlights
The pharmaceutical business was driven by growth in US sales
and other sub-segments, largely offset by de-growth in the LSI
segment due to lower oil prices and regulatory changes
The company has filed 72 ANDAs in the US till date of which 28
are pending approval
Radiopharma grew 36% YoY while the CMO business grew 27%
In the LSI business, nutrition business growth was flat in FY16
whereas specialty and life science chemicals business de-grew
10% and 19%, respectively
The company has cumulative filings of 599 and received 409
product approvals in the RoW markets through partnership and
distribution agreements
The company has added two pyridine derivative products in
FY16 and plans to add another product by Q4FY17
The pharma business margin improved to 29.1% from 16.6% in
FY15 while the LSI business margin increased to 16.3% from
10.2% in FY15
All pharmaceutical facilities were inspected successfully by the
USFDA during FY16
CMO business capacity utilisation was 65-70% in FY16
Net debt as of FY16 was | 4028 crore
What to watch
The company has planned seven to eight launches and 10-12
ANDA filings in the US in FY17
The company filed 505(2)b application with USFDA for Ruby-fill
for diagnosis of coronary heart disease through PET procedures.
The company expects to launch the same by Q4FY17
The company expects a ramp up of operations in the CMO of
sterile injectables and oral solid facilities
The company has guided for | 300 crore capex and product
development of | 150 crore for FY17
Our view
FY16 has been marked by flattish growth but ~1000 bps EBITDA margin
expansion. These have been the best margins in the last 10 years. Both
the pharma segment and LSI registered substantial margin expansion.
Note that revenues have been flattish since FY14, mainly due to LSI
segment de-growth. In this scenario, the margin expansion achievement
is admirable. Going ahead, the pharma growth is likely to sustain on the
back of robust US sales and other sub-segments while the LSI segment
may witness some growth on the back of crude oil reversal and new
launches. This improvement is unlikely to change the leverage situation

ICICI Securities Ltd. | Retail Equity Research

Page 21

overnight but things are looking much better than earlier. Given the
different fortunes of different segments in the business, we have adopted
the SOTP methodology for valuation. Our SOTP target price is | 405,
which comprise pharma value of 6x FY18E EV/EBITDA and LSI value of
4x FY18E EV/EBITDA.
Lupin

Stock Performance

Cost overrun, Goa 483 to weigh in near term

150
140
130
120
110
100
90
80
70

CNX Pharma

Lupin

Mar-16

Jan-16

Nov-15

Sep-15

Jul-15

May-15

Mar-15

60

Nifty

Key Financials
(| Crore)
Revenues
EBITDA
Net Profit
EPS (|)

FY15
12770.0
3619.6
2403.2
53.6

FY16P
14208.5
3733.4
2270.7
50.4

FY17E
17630.4
5073.9
2972.4
66.0

FY18E
20023.2
5529.8
3337.7
74.1

Debt / Equity
PE (x)
Target PE (x)
EV to EBITDA (x)
Price to book (x)
RoNW (%)

FY15
0.1
27.4
34.5
17.9
7.4
27.1

FY16E
0.6
29.2
36.7
19.4
6.0
20.7

FY17E
0.4
22.3
28.0
13.5
4.9
22.1

FY18E
0.2
19.8
25.0
11.8
3.9
19.9

RoCE (%)

35.1

18.6

22.5

23.1

Key Ratios

FY16 Highlights
Revenues grew 11.3% to | 14208.5 crore while EBITDA margins
witnessed a contraction of 200 bps to 26.3% in FY16
In FY16, 12 USFDA audits took place for its facilities. Nine of the
12 audits were without any observations. Aurangabad and
Mandideep plants EIRs had been closed while the Goa (nine
observations) plants EIR is expected to be closed soon. The Goa
facility was inspected within nine months
Total ~30% of pending ANDA approvals are from the Goa
facility. The company has started site transfer of key products
from the Goa facility to Aurangabad, Indore (SEZ) and Gavis
During the year the company acquired US generic company
Gavis for US$880 million. Gavis FY14 sales were US$96 million.
The management has guided US$300 million of revenue by
FY18. Gavis has launched 28 products in the US so far (nine
controlled substances) and 102 cumulative filings
Gavis has also added two branded products Methergine
(gynaecology) and Methylphenidate injectable (paediatric ADHD)
in Lupins US branded portfolio
Total ~| 6500 crore spike in debt in FY16 was mainly due to the
Gavis acquisition
It has also acquired companies in Brazil (Medquimica Industria
Farmaceutica SA), Russia (ZAO Biocom) and assets purchase in
Germany from Temmler Pharma
Cumulative ANDA filings were at 343 including 163 pending
approvals. The company has 45 FTF products, which includes 17
exclusive opportunities
Total 24% of the companys domestic sales are under NLEM list
In FY16, the company added 1000 MRs, established five new
divisions and launched 19 products in India of which 58% were
launched in the chronic segment
The company has a portfolio of 256 products under development
in the US
Currently 10 biosimilar products are under development in India,
one of which has entered phase III trials in Japan
R&D expenses for FY16 were 11.3%
What to watch
Lupin gave a guidance of US$3.5 billion of revenues for FY18.
Net profit margins guidance was ~20%
The company is planning 25-30 launches in the US in FY17, of
which 15 products are likely to be from Lupins Indian facilities
Lupin plans to license out three NCEs by FY18.
The company filed for first nasal spray in the US in FY16. In FY17,
it plans to file first MDI, which would be launched in FY18. Lupin
also plans to file DPI (gAdvair) in FY18, which it expects to launch
in FY19
The company expects 15% domestic growth in FY17
Lupin plans to improve its Japan business by launching new
products, seeking new partnerships and capacity expansion

ICICI Securities Ltd. | Retail Equity Research

Page 22

The company has guided for 12-15% of R&D expenses in FY17.


The increase in R&D would be on account of development of
biosimilars, new drug developments and complex generic
products. It plans to file more than 36 ANDAs in FY17
Tax guidance - 28-30% for FY17 and FY18
Guided for more than | 1000 crore capex for FY17

Our view
Revenue guidance of US$3.5 billion (earlier US$4 billion) for FY18
suggests the company has to deliver a CAGR of 28% in FY16-18E.
Despite the strong pending approval pipeline (and reiteration of Gavis
guidance of US$300 million revenues by FY18) the target does look
demanding. Similarly, incremental R&D spend, higher Gavis amortisation
and interest is likely to change the earning calculations. Accordingly, we
have scaled down our FY17E and FY18E EPS by 5% and 16%,
respectively. Goa observations are also likely to remain an overhang
despite site transfer arrangements to Indore, Aurangabad and Gavis. Our
target price is | 1850 based on 25x FY18E EPS of | 74.1. We believe the
steps taken by the management are in the right direction from a fairly
long term point of view.

ICICI Securities Ltd. | Retail Equity Research

Page 23

Exhibit 24: Notable Para IV Filings


Brand Name

Indicator

Generic Name

NDA holder

Aloxi

Nausea

palonosetron hydrochloride

Roche

Filing Date
13-Feb-15

Axiron

testosterone

hypogonadism

Eli Lilly

6-Jul-15

Beyaz

Birth control

Drospirenone

Merck

10-Oct-15

Celebrex

pain and inflammation

benzenesulfonamide

Pfizer

5-Mar-13

Daliresp

Respiratory

Roflumilast

Shire Canada

12-Mar-16

Detrol LA

overactive bladder

tolterodine tartrate

Pfizer

21-Mar-13

Effient

CVS

Prasugrel

Eli Lilly

14-Apr-15

Fanapt

Schizophrenia

Iloperidone

Vanda Pharma

24-Nov-15

Lyrica

diabetic peripheral neuroppregabalin

Pfizer Inc.

29-Apr-09

Livalo

High Cholestrol

Pitavastatin Calcium

Kowa

Lialda

Ulcerative Colitis

Mesalamine

Shire Pharma

13-Nov-15

Multaq

prevention of cardiovascudronedarone hydrochloride

Sanofi

21-May-15

Namenda

Alzheimer's Disease

Memantine Hydrochoride

Allergan

Natazia

oral contraceptive

estradiol valerate and dienogest Bayer

28-Nov-12

Nexium

acid reflux

esomeprazole magnesium

21-Oct-09

Nuvigil

excessive sleepiness ass armodafinil

Cephalon Inc., Cephalon 16-Mar-10

Pennsaid

Osteoarthritis

Diclofenac

Horizon Pharma

Paxil CR

Anxiety

Paroxetine Hydrochloride

Prevacid

gastroesophageal reflux lansoprazole

Takeda Pharma

29-Nov-12

Prezista

HIV

Tibotec Inc.

15-Nov-10

Prolensa

postoperative eye inflammbromfenac

Bausch & Lomb Inc

31-Jan-14

Pennsaid

Osteoporosis

Diclofenac

Horizon Pharma

Renagel

renal disease

sevelamer hydrochloride

Genzyme Corp.

5-Mar-09

Renvela

chronic kidney disease

sevelamer carbonate

Genzyme Corp.

14-May-09

Roxane Calcium Acet Renal Disease

NA

Roxane Lab

10-Feb-15

Savella

fibromyalgia

milnacipran

Forest Lab

23-Sep-13

Safyral

Birth Control

Drospiranone; Ethinyl Estradiol; L Merck

15-May-15

darunavir

3-May-15

21-Aug-15

AstraZeneca AB

24-Sep-15

Apotex Inc.

1-May-15

3-Apr-15

Tamiflu

Influenza

Oseltamivir

Gilead Sciences Inc.

12-Sep-15

Toviaz

overactive bladder

fesoterodine fumarate

Pfizer

28-Jun-13

TravatanZ

elevated intraocular presstravoprost ophthalmic solution

Alcon Research

20-Jul-15

Truvada

HIV

tenofovir disoproxil fumarate/emtGilead Sciences

16-Aug-12

Uceris

GI

Budesonide

Cosmo Techs

18-Nov-15

Uloric

gout

febuxostat

Takeda

12-Feb-14

Vimovo

osteoarthritis, rheumatoidnaproxen / esomeprazole magnesAstrazeneca

Viread

HIV

Welchol

high cholesterol and type colesevelam hydrochloride

Daiichi Sankyo Inc.

30-Jul-10

Nuvigil

excessive sleepiness ass armodafinil

Cephalon Inc.

2-Nov-11

Revlimid

myelodysplastic syndromlenalidomide

Celgene Corp.

Tamiflu

influenza

Roche

15-Mar-11
27-May-14

tenofovir disoproxil fumarate

oseltamivir phosphate

25-Jul-11

Gilead Sciences

20-Aug-12

8-Oct-10

Treanda

chronic lymphocytic leukebendamustine

Cephalon Inc.

Apriso

ulcerative colitis

mesalamine

Salix Pharmaceuticals I

Exelon

dementia

rivastigmine

Novartis

3-Apr-13

Lyrica

diabetic peripheral neuroppregabalin

Suprep

laxative

sodium / potassium / magnesiumBraintree Laboratories,

Xyrem

Narcolepsy

Sodium Oxybate

Pfizer
Jazz Pharma

18-Feb-14
7-Jan-11
9-Mar-11
13-Sep-15
[

Source: Bloomberg, ICICIdirect.com Research; Included Subsidiaries filings

ICICI Securities Ltd. | Retail Equity Research

Page 24

Natco Pharmaceuticals

Stock Performance

Hepatitis C group sales drive FY16 growth

150
140
130
120
110
100
90
80
70

CNX Pharma

Natco Pharma

Mar-16

Jan-16

Nov-15

Sep-15

Jul-15

May-15

Mar-15

60

Nifty

Key Financials
(| crore)
Revenues
EBITDA
Net Profit
EPS (|)

FY15
825.3
213.4
151.4
8.3

FY16P
1141.6
269.7
155.2
8.9

FY17E
1348.8
303.5
190.6
10.9

FY18E
1554.5
357.5
227.0
13.0

FY15
0.4
61.7
34.3
39.2
10.0
17.9
15.4

FY16E
0.1
52.0
32.0
30.0
6.2
12.0
16.1

FY17E
0.1
42.3
26.0
26.9
5.5
13.0
16.4

FY18E
0.1
35.5
21.9
22.8
4.9
13.7
17.3

Key Ratios
Debt / Equity
PE (x)
Target PE(x)*
EV to EBITDA (x)
Price to book (x)
RoNW (%)
RoCE (%)

FY16 Highlights
Revenues increased 38% YoY to | 1142 crore mainly due to
strong sales in Hepatitis C segments. Hepatitis C (ex third party)
sales were ~| 256 crore in FY16 compared to | 17 crore in FY15
The company has filed Hepatitis C products in 40 countries and
received approval in eight countries
EBITDA margins declined ~240 bps YoY to 23.6% mainly due to
higher other expenditure, which mainly comprised third-party
profit sharing for the procurement of Hepatitis C APIs
The cumulative ANDA filings were at 38 including 16 Para IV. The
company filed four ANDAs during FY16 of which three were Para
IV filings and one was an FTF
R&D spend for FY16 was ~| 70 crore
During the fiscal, it sold US based Save Mart pharmacy store
The company received USFDA observations on its API facility at
Manali, near Chennai, and formulations facility at Kothur, near
Hyderabad. Both these facilities were inspected by the USFDA
during February and March
What to Watch
The management gave a revenue guidance of ~| 1350 crore and
net profit guidance of ~| 175 crore of net profit
The management expects ~| 850 crore domestic sales in FY17
with Hepatitis C portfolio contributing ~| 500 crore, oncology
business | 280-300 crore and | 65-75 crore of third party sales
The management expects the Hepatitis C branded segment to
contribute | 125-140 crore every quarter with EBITDA margins of
30%
It expects gTamiflu (anti-infective), gCopaxone (oncology),
gFosrenol (kidney disease) and gEntocort (anti-inflammatory)
USFDA approvals in FY17
The company is planning launch of gDoxil (anti-cancer) by FY18
It is planning six to seven filings in FY17 with brand sales of
~US$3 billion. Total ~50% of filings will be oncology filings. As
per the company, most filings are expected to be Para IV
opportunities
The company expects to receive EIR for its Chennai API facility
and Kothur, Telangana formulations facility
R&D spend is expected to be 6-7% of sales in FY17
Guided for | 270-280 crore of capex for FY17 of which, | 100
crore earmarked for Vizag facility, | 130 crore for expansion of
Hyderabad and Chennai facilities, ~| 30 crore for Dehradun and
Guwahati formulation facilities and ~| 40 crore for Kothur
formulation facility
The company plans to commercialise the Vizag facility by the end
of FY17
Guided for 21% tax rate for FY17 and FY18
Our View
Sofosbuvir (and combination) sales in India have become the main
catalyst for growth besides legacy segments. This augurs well in the long
run as the domestic portfolio was mostly dependent on oncology offtake. Despite possible crowding in the Hepatitis C space we expect the
product to generate significant cash flows from India and other emerging
markets, going ahead. On the export front, the US would remain a key

ICICI Securities Ltd. | Retail Equity Research

Page 25

long term driver base on its strong complex FTF/Para IV filings. We


continue to value the stock on an SoTP basis to capture the emerging
FTF/limited competition opportunities in the US. We arrive at a target
price of | 600 including base business value of | 287 (22x FY18E EPS of
| 13.0) + | 313 for NPV of other FTF/Para IVs.
Sun Pharmaceuticals

Stock Performance

Conservative guidance; Halol resolution key near term catalyst

150
140
130
120
110
100
90
80
70

CNX Pharma

Sun Pharma

Mar-16

Jan-16

Nov-15

Sep-15

Jul-15

May-15

Mar-15

60

Nifty

Key Financials
(| Crore)
Net Sales
EBITDA
Adj. Profit
Adj. EPS (|)

FY15
27433.4
7866.7
4777.1
19.8

FY16P
28563.0
8724.3
5652.6
23.4

FY17E
31525.9
9670.1
6324.5
26.2

FY18E
34205.3
11132.8
7557.7
31.3

FY15
0.4
41.4
23.4
7.3
18.6
18.8

FY16E
0.3
37.9
20.8
6.0
18.0
18.6

FY17E
0.1
29.7
18.1
5.1
17.3
19.5

FY18E
0.1
24.9
15.2
4.4
17.6
20.1

Key Ratios
Debt / Equity
PE (x)
EV to EBITDA (x)
Price to book (x)
RoNW (%)
RoCE (%)

FY16 highlights
Revenues grew mere 4.1% to | 28563 crore on account of
USFDA issues at its Halol facility and Ranbaxy consolidation.
EBITDA margins grew ~180 bps to 30.5% during the year
The company launched gGleevec (oncology) under exclusivity in
Q4FY16. The annual sale of the drug is ~US$2 billion in the US
Announced positive results of phase-III clinical trials for
Tildrakizumab (plaque psoriasis) in the US
The company forayed into the Japanese branded market by
acquiring 14 prescription brands from Novartis for a cash
consideration of US$293 million. These brands have combined
annualised revenues of ~US$160 million
Taro has received NDA approval from USFDA for Keveyis
(dichlorphenamide) 50 mg Tablets for the treatment of primary
hyperkalemic and hypokalemic periodic paralysis. However, the
response was not up to the mark
Suns cumulative ANDAs were at 572 including 159 pending
approvals (includes 13 tentative approvals). In FY16, it filed 22
(including 10 filings from Taro pharma) ANDAs and received 14
approvals. During FY16, the company did not file for any
complex generic products
The company received USFDA approval for its NDA BromSite
(bromfenac ophthalmic solution; market size of ~US$400 million)
used for the treatment of postoperative inflammation and
prevention of ocular pain in patients undergoing cataract surgery
Suns capex for FY16 was less than | 1000 crore
The Board of Directors has proposed a buy-back of equity shares
of the company
R&D spend for FY16 was 8.3% of revenues
What to watch
The management gave a revenue guidance of 8-10% for FY17
The company is planning a re-inspection request to USFDA for
Halol facility in Q1FY17
In the US, the company plans to launch NDA BromSite
(bromfenac ophthalmic solution) in Q2FY17. It expects approval
for another NDA for ophthalmic product. The company currently
has MR strength of 100 for this portfolio
Expects a pricing impact of 5-10% for its US base business in
FY17 on account of increased competition
The company plans to offer one Ranbaxy facility to the USFDA
for re-certification
It is planning a capex of US$250 million for Tildrakizumab, the IL23 monoclonal anti-body in-licensed from MSD (US) over four to
five years to be utilised for its psoriasis trials
The company is in the process of receiving marketing
authorisation for an acquired portfolio of 14 brands from Novartis
in Japan. It expects the business to contribute to the total
turnover from H2FY17
In FY17, Sun guided for R&D spend of 9% of the turnover
The company gave a tax rate guidance of 14-15% for FY17

ICICI Securities Ltd. | Retail Equity Research

Page 26

Our View
The management guidance for revenue growth of 8-10% looks a bit
conservative given the residual traction from gGleevec (four months
exclusivity), Japanese traction from H2 and likely product launches in
H2FY17 from Halol (assuming USFDA resolution). This indicates that the
management is expecting some genuine pricing pressure in the US base
business. The proposed buy-back is also likely to be perceived negatively
given the companys knack of deploying cash for successful acquisitions
in the past. On the Tildrakizumab front, the progress is encouraging but
back-loaded. In the near term, Halol and the US base business
headwinds are likely to weigh. We have ascribed a target price of | 785
based on 25x FY18E EPS of | 31.3.
Exhibit 25: Notable Para IV Filings
Brand Name

Indicator

Generic Name

NDA holder

Acanya

severe acne

benzoyl peroxide

Dow Pharma

13-Aug-14

Alimta

lung cancer; mesotheliompemetrexed disodium

Eli Lilly

13-Sep-13

Allegra

seasonal allergies

Aventis Pharmaceutical

9-Oct-09
23-Jan-09

fexofenadine hydrochloride

Filing Date

Allegra-D

seasonal allergies

fexofenadine hydrochloride / pseuAventis Pharmaceutical

Ampyra

Multiple Sclerosis

Dalframpridine

Acorda Therapeutics Inc 12-May-15

AMPYRA

multiple sclerosis

Dalfampridine

Alkermes Pharma

18-May-15

Angiomax

anticoagulant for coronar bivalirudin

Medicis Pharma

21-Nov-11

Crestor

high cholesterol

AstraZeneca Pharmace

26-Apr-10

Effient

acute coronary syndromeprasugrel hydrochloride

Eli Lilly

12-Mar-14

Epiduo

Acne

Adapalene & Benzoyl peroxide

Galderma Labs

12-Aug-15

GanirelixAcetate

IVF

ganirelix acetate

Merck

27-Aug-12

Lyrica

diabetic peripheral neuroppregabalin

Pfizer Inc.

29-Apr-09

Moviprep

Gastro Intestinal

rosuvastatin calcium

Polyethylene glycol electrolyte soSalix Pharmaceuticals,

2-Oct-15

Multaq

cardiovascular hospitalizadronedarone hydrochloride

Sanofi

Naftin

Fungal Infection

Naftifine Hydrochloride

Merz Pharma

14-May-15

Onexton

Acne

Cindamycin Phosphate and BenzoDow Pharma

12-Jan-16

Onglyza

type II diabetes

Ortho TRI-Cyclen LO oral contraceptive

Saxagliptin

6-Mar-14

Astrazeneca

3-Jun-14

ethinyl estradiol; norgestimate) Purdue Pharma

8-Apr-11

Reclast

osteoporosis and Paget's zolendronic acid

Novartis Pharma

20-Feb-13

Reclast

osteoporosis and Paget's zolendronic acid

Novartis Pharma

14-Jul-12

Savella

fibromyalgia

milnacipran

Forest Lab

Suprep

colon cleansing

sodium sulfate

Braintree Lab

Taclonex

psoriasis vulgaris

calcipotriene / betamethasone di Cancer Research Tech.

Treanda

chronic lymphocytic leukebendamustine

Treximet

migraine

sumatriptan / naproxen sodium Pozen Inc.

26-Nov-11

Uloric

gout

febuxostat

Takeda

12-Feb-14

Cephalon Inc.

23-Sep-13
9-Oct-14
15-Sep-10
26-Dec-13

Vascepa

hypertriglyceridemia

icosapent ethyl

Amarin Pharma

20-Jun-14

Velcade

cancer

bortezomib

Millennium

25-Jun-15

Xyrem

narcolepsy

paracetamol

Jazz Pharma

Yaz

contraception; acne; premdrospirenone / ethinyl estradiol Bayer

12-Jan-11

Zemplar

secondary hyperthyroidis paricalcitol

24-Jan-13

AbbVie Inc

2-Oct-14

Source: Bloomberg, ICICIdirect.com Research; *Included Subsidiaries filings

ICICI Securities Ltd. | Retail Equity Research

Page 27

Syngene International

Stock Performance

Compelling non-generic option with thrust on capex

200
180
160
140
120
100
80

CNX Pharma

Feb-16

Dec-15

Aug-15

Oct-15

60

Syngene Int

Nifty

Key Financials
(|crore)

FY15

FY16P

FY17E

FY18E

Revenues

859.9

1107.0

1411.6

1707.0

EBITDA

281.1

357.8

458.2

575.2

Net Profit

175.0

221.2

311.7

371.0

8.8

11.1

15.6

18.5

EPS (|)

PE (x)
M.Cap/ Revenues (x)
EV to EBITDA (x)

What to watch

Key Ratios
Debt / Equity

FY16 Highlights
Revenues grew 28.7% to | 1107 crore while EBITDA margins
remained flattish at 32.3%
Realisation was muted in FY16 as the company passed on the
currency benefits to customers
In FY16, top 10 clients contributed 69% to revenues as compared
to 71% in FY15
Dedicated services, discovery services and development &
manufacturing services contributed ~33%, ~27% and ~40%,
respectively, to FY16 revenues
During FY16, the company cleared three USFDA inspections
without any major observations
The company increased its client base to 256 from 221 in FY15
Number of scientists has gone up from 2227 in FY15 to 2571 in
FY16 with total employees from 2656 in FY15 to 2967 in FY16
The company has raised US$100 million via ECB for the
construction of Mangalore facility and other capex

FY15

FY16P

FY17E

0.2

0.9

0.6

FY18E
0.5

42.5

33.6

23.9

20.1

8.6

6.7

5.3

4.4

26.1

20.5

16.7

13.1

P/B (x)

8.8

7.1

5.6

4.5

ROE (%)

20.7

21.2

23.5

22.4

RoCE (%)

19.5

13.3

16.7

18.2

Guided for US$250 million of revenue by FY18E with EBITDA


margins of ~33% (including other income) and PAT margins of
~20%
It has planned a capex of US$200 million from FY16-18E for 1)
setting up a commercial scale manufacturing centre in Mangaluru
(~US$100 million), 2) new research centre (~US$50 million), 3)
capacity expansion in its developmental services and cGMP drug
substance manufacturing and 4) biologics plant, viral testing
services and antibody-drug conjugate (ADCs). The company has
already spent ~US$50 million in FY16
Biological centre to start commercial operations from FY18
The company has guided ~3% annual increment in realisation
Late stage (phase IIb and phase III) molecules are currently at
high single digit in the development pipeline.
The company expects its Mangaluru facility to be operational
from FY19 and reach its peak occupancy (~70%) by FY21
The company gave tax rate guidance of ~14% for FY17
and~16% for FY18.

Our View
In the crowded Indian pharma space dominated by generic exporters,
SIL stands out as an atypical candidate with new molecular entity (NME)
focus. It is well poised to capture opportunities in the global CRO space
on account of strategic outsourcing by global innovators in the backdrop
of structural challenges such as an impending patent cliff, controlling
costs and keeping new products introduction flow intact. Its proven
capabilities have been backed by robust financials, which have been
fairly consistent, thanks to regular customer addition and stickiness of
existing customers. This is also on account of continuous broadening of
services offering by the company since inception. We expect sales,
EBITDA and PAT to grow at a CAGR of 24.2%, 26.8% and 29.5% to
| 1707.0 crore, | 575.2 crore and | 371.0 crore, respectively, between
FY16P and FY18E. We have ascribed a target price of | 445 based on 24x
FY18E EPS of | 18.5.

ICICI Securities Ltd. | Retail Equity Research

Page 28

Torrent Pharma

Stock Performance

US, India key catalysts for future

150
140
130
120
110
100
90
80
70

CNX Pharma

Torrent Pharma

Mar-16

Jan-16

Nov-15

Sep-15

Jul-15

Mar-15

May-15

60

Nifty

Key Financials
(|crore)
Revenues
EBITDA
Net Profit
EPS (|)

FY15
4653.0
1020.0
750.9
44.4

FY16P
6813.0
2857.0
1954.8
115.5

FY17E
6044.7
1654.5
1147.0
67.8

FY18E
6708.6
1777.8
1269.6
75.0

FY15
1.1
31.1
37.2
24.8
9.4
30.2
20.1

FY16E
0.6
11.7
14.3
8.3
6.9
57.7
51.1

FY17E
0.3
20.4
24.3
14.2
5.5
27.0
27.0

FY18E
0.2
18.4
22.0
12.8
4.5
24.4
26.8

Key Ratios
Debt / Equity
PE (x)
Target PE (x)
EV to EBITDA (x)
Price to book (x)
RoNW (%)
RoCE (%)

FY16 Highlights
Revenues grew 46.4% to | 6813 crore mainly on account of
gAbilify launch under exclusivity in the US. EBITDA margins
consequently grew ~2000 bps to 41.9% owing to traction from
gAbilify exclusivity.
Domestic formulations (27% of total revenue) grew 13% YoY to
| 1825 crore mainly due to consolidation of Elder's portfolio
The impact of NLEM 2015 accounts for 1-2% of domestic sales
In FY16, the company launched two biosimilars Rituximab (anticancer) and Adalimumab (anti-inflammatory) in India.
The company launched tenegliptin (anti-diabetic) in India in FY16
During FY16, the company launched five new products, namely,
gAbilify (aripiprazole- CNS), domperidone (GI), gNexium
(esomeprazole-GI), gExforge (CVS) and gExforge HCT (CVS) in
the US.
During FY16, the companys Dahej, Indrad and Indore
dermatology facility were inspected by the USFDA. The company
received EIR for Dahej facility, while Indrad facility received two
or three minor 483 observations
As per the company, its market share in gAbilify (aripiprazoleCNS) is more than 4% in the US and gNexium (esomeprazole-GI)
is ~4%, which is expected to increase to 5-7%, going forward
The company has 15% market share for gDetrol (tolterodine)
used to treat urinary ailments. The company expects its share to
increase going forward.
What to watch
Torrent expects eight to 10 launches (including couple of limited
competition launches) in the US in FY17
It plans to file three to four ANDAs through Zyg Pharma and 1015 filings from Dahej facility in FY17
Currently, the company is working on 121 R&D projects. It signed
nine collaboration agreements with external partners and are on
track to file about 15-20 ANDAs in FY17
Torrent expects to receive EIR for Indrad facility in FY17
The R&D spend in FY16 was ~4% of sales. The company expects
this to go up to 8% of sales in FY17. Torrent plans to increase its
R&D spend for Brazil and India along with the US
The company has planned a capex of | 1500 crore for the next
two to three years (| 400-500 crore annually).
Torrent is looking for an acquisition in the range of US$300-600
million, with major focus on the US institutional business
The company gave a tax rate guidance of 23% for FY17
Our View
The US remains on a strong growth path with the launch of gAbilify
under the shared exclusivity, which is the second such product after
gCymbalta. These kinds of windfall free cash flows are likely to bring
down the leverage position and will pave the way for further acquisitions.
Going ahead, the US and India will be pillars for future growth driven by
new product launches and improvement in market share. However, the
macroeconomic headwind in Brazil would dent overall growth. We have
ascribed a target price of | 1650 (22x FY18E EPS of 75.0).

ICICI Securities Ltd. | Retail Equity Research

Page 29

Exhibit 26: Notable Para IV Filings


Brand Name

Indicator

Generic Name

NDA holder

Benicar

Anti-depressant

Olmesartan

Daiichi Sankyo

21-Mar-16

Bystolic

Hypertension

nebivolol

Forest Lab

13-Mar-12

Crestor

high cholesterol

rosuvastatin calcium

AstraZeneca Pharmace

Daliresp

Chronic Obstructive PulmRoflumilast

AstraZeneca

15-May-15

Viagra

erectile dysfunction

Pfizer

17-Mar-14

pyrazolopyrimidinones

Filing Date

8-Jul-10

Source: Bloomberg, ICICIdirect.com Research

Unichem Laboratories

Stock Performance

Revenue growth recovers but margins still under pressure

200
180
160
140
120
100
80

CNX Pharma

Unichem Labs

Mar-16

Jan-16

Nov-15

Sep-15

Jul-15

May-15

Mar-15

60

Nifty

Key Financials
(| crore)
Revenues
EBITDA
Adj. Net Profit
Adj. EPS (|)

FY15 FY16P
1201.8 1334.6
101.3 163.9
75.3 111.6
8.3
12.3

FY17E
1569.4
204.0
140.9
15.5

FY18E
1821.7
273.2
200.6
22.1

FY17E
0.0
16.8
19.9
11.6
2.2
13.4
16.2

FY18E
0.0
11.8
14.0
8.3
2.0
16.8
20.4

Key Ratios
Debt/Equity (x)
PE (x)
Target PE (x)
EV to EBITDA (x)
Price to book (x)
RoNW (%)
RoCE (%)

FY15
0.0
31.5
37.3
23.0
2.7
8.7
8.5

FY16E
0.0
21.8
25.2
14.5
2.5
11.7
13.8

ICICI Securities Ltd. | Retail Equity Research

FY16 Highlights
Revenues grew 11% to | 1334.6 crore mainly due to strong
growth in the US and recovery in domestic market (albeit on
lower base). Domestic revenue grew 14.1% to | 742.9 crore and
export formulation grew 17.7% to | 368.1 crore.
EBITDA margins improved ~390 bps to 12.3% due to a better
product mix, which was partially offset by increased employee
strength, additional bonus paid accordance with amendment in
Bonus Act and higher cost in the US
Total ANDAs filing was at 36 of which, the company has
launched 14 products and awaiting approvals for 16 ANDAs. The
company reported cumulative DMF filings to 46
The CRAMS business accounts for 10% of total standalone sales
of | 1222.4 crore. YoY growth for CRAMS was flat in FY16
The company received establishment inspection report (EIR) post
re-inspection of three plants in Goa, Ghaziabad and Roha
Total six to seven new products were added in the NLEM list in
FY16. Currently, 21-22% of the domestic portfolio is under NLEM
while 2-2.5% of the portfolio is under the FDCs banned by the
Government of India
As of FY16, the company has ~250 scientists, more than 2500
MRs and total employee strength of ~5500
The capacity utilisation at the company level is 60-70%
Total ~90% of the companys formulation business is backward
integrated
The company has so far launched more than 15 products from its
Niche Generics subsidiary, UK
Unichem has launched two products in the Brazilian markets
R&D expenses for FY16 were 4-5% of total sales
What to watch
Operating margins are expected to improve 100-150 bps in FY17
on account of a better product mix and sales growth
The company is planning | 150-200 crore of capex for FY17 and
FY18, mostly for the API facility in Kolhapur. Rest of the capex
would be utilised for maintenance and de-bottlenecking of its
existing facilities
The company is planning one or two ANDA filings every quarter
and six to eight filings annually. Unichem is planning two product
launches in Q1FY17 and one or two launches in Q2FY17
The company plans to launch two products in Brazil (approved
by ENVISA) by Q2FY17
Unichem has guided an R&D spend at ~5% of total sales, going
forward
Guided for tax rate of ~24% for FY17 and FY18

Page 30

Our View
Domestic formulations growth has shown signs of recovery in FY16. The
managements focus on restructuring the matured portfolio, which
accounts for 46% of the overall pie and that comprises legacy but slow
moving brands, seems to be working. Despite a better product mix, the
margin remained under pressure. Higher employee expenses and oneoff pertaining to provision of subsidiary investment have dented margins.
The next task for the management is to bring dwindling margins to the
industry level. Export formulations are likely to maintain the growth
tempo on the back of incremental US filings and subsequent launches.
We expect revenues, EBITDA, profit to grow at a CAGR of 16.8%, 29.1%
and 34.1%, respectively, in FY16P-18E. We have ascribed a target price
of | 310, based on 14x FY18E EPS of | 22.1.

ICICI Securities Ltd. | Retail Equity Research

Page 31

Exhibit 27: USFDA approvals for companies under I-Direct coverage in FY16
Date

Company

Drug Name

Therapeutic Area

Innovator company

Generic Version of

Market Size

15-Aug

Ajanta Pharma

Monteculast Sodium

CVS

Merck

Singulair

US$ 3.5 billion

15-Nov

Ajanta Pharma

Memantine Hydrochloride

CNS

Forest Labs

Namenda

US$ 1.1 billion

16-Mar

Ajanta Pharma

Almotriptan Malate

CNS

Janssen Pharma

Axert

NA

15-Dec

Ajanta Pharma

Irbesartan

CVS

Sanofi Aventis

Avapro

US$ 1.23 billion

15-Jun

Alembic Pharma

Lithium Carbonate

Anti-psycotic

Ani Pharms

Lithobid

US$ 21 million

15-Jun

Alembic Pharma

Desvenlafaxine Succinate

Anti-Depressant

Wyeth Pharms

Pristiq

US$ 600 million

15-Aug

Alembic Pharma

Celecoxib

Anti-Inflammatory

Go Searle

Celebrex

US$ 2.44 billion

15-Sep

Alembic Pharma

Zolmitriptan

CNS

IPR

Zomig

US$ 152.8 million

15-Oct

Alembic Pharma

Memantine Hydrochloride

CNS

Forest Labs

Namenda

US$ 1.1 billion

15-Dec

Alembic Pharms

Linezolid

Anti-bacterial

Pharmacia and Upjohn

Zynox

NA

15-Apr

Aurobindo Pharma

Sildenafil Citrate

Harmonal

Pfizer

Revatio

US$ 300 million

15-Apr

Aurobindo Pharma

Atracurium Besylate

CNS

Hospira

Tracrium

NA

15-Apr

Aurobindo Pharma

Cefixime

Antibiotic

Lederle

Suprax

US$ 123 million

15-Jun

Aurobindo Pharma

Phenytoin Sodium

Anti-Epileptic

Parke Davis

Dilantin

US$ 125 million

15-Jun

Aurobindo Pharma

Azithromycin

Anti-Infective

Pfizer

Zithromax

NA

15-Jun

Aurobindo Pharma

Entacapone

CNS

Orion Pharma

Comtan

US$ 82 million

15-Jul

Aurobindo Pharma

Flecainide Acetate

CVS

Cnty Line Pharms

Tambocor

US$ 61 million

15-Jul

Aurobindo Pharma

Esmolol Hydrochloride

CVS

Baxter Hlthcare

Brevibloc

US$ 49 million

15-Aug

Aurobindo Pharma

Alprazolam

CNS

Pharmacia & UpJohn

Xanax

US$ 26.5 million

15-Aug

Aurobindo Pharma

Cetrizine Hydrochloride Allergy

Anti-histamine

McNeil Consumer

Zyrtec Allergy

US$ 146.3 million

15-Aug

Aurobindo Pharma

Omeprazole

Gastro Intestinal

Astrazeneca

Prilosec

US$ 185 million

15-Aug

Aurobindo Pharma

Ibandronate Sodium

Osteoporosis

Roche

Bonva

US$ 450 million

15-Aug

Aurobindo Pharma

Entecavir

Anti-viral

Bristol Myers Squibb

Baraclude

US$ 328 million

15-Aug

Aurobindo Pharma

Raloxifene Hydrochloride

Osteoporosis

Lilly

Evista

US$ 209.3 million

15-Sep

Aurobindo Pharma

Gemfibrozil

CVS

Pfizer

Lopid

US$ 44 million

15-Sep

Aurobindo Pharma

Telmisartan

CVS

Boehringer Ingelheim

Micardis

US$ 250 million

15-Sep

Aurobindo Pharma

Caffeine Citrate

CNS

Eurohlth Intl Sarl

Cafcit

NA

15-Oct

Aurobindo Pharma

Tramadol Hydrochloride

Anti-inflammatory

Valeant Intl

Ultram ER

US$ 132 million

15-Oct

Aurobindo Pharma

Memantine Hydrochloride

CNS

Forest Labs

Namenda

US$ 1.1 billion

15-Oct

Aurobindo Pharma

Aripiprazole

CNS

Otsuka

Abilify

US$ 7.8 billion

15-Nov

Aurobindo Pharma

Sildenafil Citrate

Erectile Dysfunction

Pfizer

Revatio

US$ 300 million

15-Nov

Aurobindo Pharma

Risedronate Sodium

Osteoporosis

Warner Chilcott LLC

Actonel

US$ 180 million

15-Nov

Aurobindo Pharma

Methylprednisolone Sodium Succinate

Anti-Allergy

Pharmacia & Upjohn

Solu-Medrol

US$ 102 million

15-Nov

Aurobindo Pharma

Loperamide Hydrochloride

GI

Johnson & Johnson

Imodium

US$ 9.7 million

15-Dec

Aurobindo Pharma

Risedronate Sodium

Osteoporosis

Warner Chilcott

Actonel

US$113 million

15-Dec

Aurobindo Pharma

Loperamide Hydrochloride

GI

J and J Consumer Inc.

Imodium

US$ 9.7 million

15-Dec

Aurobindo Pharma

Methylprednisolone Sodium Succinate

Anti-Inflammatory

Pharmacia and Upjohn

Solu-Medrol

US$ 102 million

16-Jan

Aurobindo Pharma

Norethindrone Acetate

Gynacology

Duramed Res

Aygestin

US$ 24 million

16-Jan

Aurobindo Pharma

Tranexamic Acid

Hemophiliac

Pharmacia and Upjohn

Cyklokapron

US$ 50 million

16-Jan

Aurobindo Pharma

Paricalcitol

Hormonal

Abbvie

Zemplar

US$ 110 million

16-Jan

Aurobindo Pharma

Voriconazole

Anti-Infection

PF Prism CV

Vfend

US$ 103 million

16-Feb

Aurobindo Pharma

Levetiracetam

Anti-epileptic

UCB Inc

Keppra

US$ 1.2 billion

16-Feb

Aurobindo Pharma

Celecoxib

Anti-Inflammatory

GD Searle

Celebrex

US$ 2.44 billion

16-Feb

Aurobindo Pharma

Isosulfan Blue

Diagnostic Agent

Covidien

Lymphazurin

NA

16-Feb

Aurobindo Pharma

Levofloxacin

Anti-infective

Janssen Pharma

Levaquin

US$1.45 billion

Source: USFDA website, ICICIdirect.com Research; * Subsidiary of Sun Pharma

ICICI Securities Ltd. | Retail Equity Research

Page 32

Exhibit 28: USFDA approvals for companies under I-Direct coverage in FY16
Date

Company

Drug Name

Therapeutic Area

Innovator company

Generic Version of

Market Size

16-Feb

Aurobindo Pharma

Acetylcysteine

CVS

Cumberland Pharma

Acetadote

NA

16-Mar

Aurobindo Pharma

Ibandronate Sodium

Osteoporosis

Hoffmann La Roche

Boniva

US$ 55 million

16-Mar

Aurobindo Pharma

Dexmedetomidine Hydrochloride

Anesthesia

Hospira

Precedex

US$ 59.1 million

16-Mar

Aurobindo Pharma

Naproxen Sodium

Anti-inflammatory

Alvogen

Naprelan

US$ 96 million

16-Mar

Aurobindo Pharma

Rivastigmine Tartrate

CNS

Novartis

Exelon

US$ 26.7 million

16-Mar

Aurobindo Pharma

Vancomycin HCl

Antibiotic

Fresenius Kab

Vancomycin HCl

US$ 160 million

16-Mar

Aurobindo Pharma

Pantoprazole Sodium

Gastro Intestinal

Wyeth Pharma

Protonix

US$ 93.5 million

16-Mar

Aurobindo Pharma

Valganciclovir Hydrochloride

Antiviral

Hoffmann La Roche

Valcyte

US$ 94 million

15-Dec

Aurobindo Pharma

Eptifibatide

CVS

Schering

Integrilin

US$ 137 million

15-Dec

Aurobindo Pharma

Levonorgestrel

Oral-Contraceptive

Teva

Plan-B

US$ 64 million

15-Dec

Aurobindo Pharma

Dexamethasone Sodium Phosphate

Anti-Inflammmatory

Merck

Decadron

US$ 31 million

15-Dec

Aurobindo Pharma

Olopatadine Hydrochloride

Opthalmic

Alcon Pharms

Pataday

US$ 235 million

15-Dec

Aurobindo Pharma

Famotidine

GI

Valeant Pharms

Pepcid

US$ 29 million

15-Aug

Aurolife

Methadone Hydrochloride

Pain Management

Mallinckrodt

Methadone

NA

16-Mar

Cadila Healthacare

Dextroamphetamine IR Tablets

CNS

Amedra Pharma

Dexedrine

US$ 40.6 million

16-Mar

Cadila Healthacre

Acyclovir

Antiviral

Cipher Pharma

Sitavig

NA

15-Jun

Cadila Healthcare

Pyridostigmine Bromide

CNS

Valeant Pharms

Mestinon

US$ 27.9 million

15-Jun

Cadila Healthcare

Calcium Acetate

Blood phosphate

Cypress Pharm

Eliphos

NA

15-Aug

Cadila Healthcare

Amiloride Hydrochloride

CVS

Paddock LLC

Midamor

NA

16-Feb

Cadila Healthcare

Doxycycline

Anti-Infective

Aqua Pharma

Monodox

US$ 181 million

16-Feb

Cadila Healthcare

Glyburide; Metformin Hydrochloride

Anti-diabetic

Bristol Myers Squibb

Glucovance

NA

16-Mar

Cipla (Invagen Pharma) Olanzapine

CNS

Lilly

Zyprexa

US$ 3.2 billion

15-Aug

Dr. Reddy's Labs

Pramipazole Dihydrochloride

CNS

Boehinger Ingelhem

Mirapex ER

NA

15-Sep

Dr. Reddy's Labs

Esomeprazole Magnesium

GI

Astrazeneca Pharma

Nexium

US$ 7.3 billion

15-Dec

Dr. Reddy's Labs

Amoxicillin

Anti-bacterial

GSK

Amoxil

NA

15-Apr

Glenmark

Ethinyl Estradiol; Levonorgestrel

Contraceptive

Wyeth Pharms

Alesse

US$ 6.4 million

15-Apr

Glenmark

Ethinyl Estradiol; Norethindrone Acetate

Contraceptive

Warner Chilcott

Estrostep

US$ 38.6 million

15-May

Glenmark Pharma

Desmopressin Acetate

Respiratory

Ferring Pharma

Minirin

NA

15-Jun

Glenmark Pharma

Calcipotriene

Vitamins

Leo Pharma

Dovonex

US$ 92.8 million

15-Jun

Glenmark Pharma

Levonorgestrel and Ethinyl Estradiol

Oral Contraceptive

Teva

Seasonale

US$81 million

15-Aug

Glenmark Pharma

Drosperenone and Ethinyl Estradiol

Gynecolgy

Bayer Hlthcare

Yaz

US$ 347 million

15-Sep

Glenmark Pharma

Voriconazole

Anti-Infection

PF Prism CV

Vfend

US$ 800 million

15-Oct

Glenmark Pharma

Betamethasone Dipropionate; Clotrimazole

Dermatology

Merck Sharp Dohme

Lotrisone

NA

16-Jan

Glenmark Pharma

Potassium Chloride

Hypokalemia

Upsher Smith

Klor-Con

US$ 74.1 million

16-Jan

Glenmark Pharma

Norethindrone Acetate and Ethinyl Estradiol

CVS

Warner Chilcott

Loestrin

US$ 56.8 million

16-Feb

Glenmark Pharma

Norgestimate; Ethinyl Estradiol

Oral Contraceptives

Sandoz

Tri-lo-estarylla

US$ 420 million

16-Mar

Glenmark Pharma

Frovatriptan Succinate

CNS

Endo Pharma

Frova

US$ 87.8 million

16-Mar

Glenmark Pharma

Raloxifene Hydrochloride

Osteoporosis

Lilly

Evista

US$ 336.5 million

16-Mar

Glenmark Pharma

Bendamustine Hydrochloride

Anti-cancer

Cephalon

Treanda

US$ 92.6 million

16-Mar

Glenmark Pharma

Drospirenone; Ethinyl Estradiol

Oral Contraceptive

Bayer Healthcare

Yaz

US$ 347 million

16-Mar

Glenmark Pharma

Levonorgestrel

Oral-Contraceptive

Teva

Plan-B

US$ 64 million

15-Dec

Glenmark Pharms

Linezolid

Anti-bacterial

Pharmacia and Upjohn

Zynox

US$ 447.6 million

16-Feb

InvaGen Pharma

Bupropion Hydrochloride

Anti-depressant

GSK

Wellbutrin

US$ 268 million

15-Jun

Jubilant Life Sciences

Levofloxacin

Anti-infective

Ortho McNeil Janseen PhaLevaquin

US$1.45 billion

Source: USFDA, ICICIdirect.com Research; * subsidiaries of Sun Pharma

ICICI Securities Ltd. | Retail Equity Research

Page 33

Exhibit 29: USFDA approvals for companies under I-Direct coverage in FY16
Date

Company

Drug Name

Therapeutic Area

Innovator company

Generic Version of

Market Size

15-Sep

Jubilant Life Sciences

Zolmitriptan

CNS

Astrazeneca

Zomig

US$ 152.8 million

15-Oct

Jubilant Life Sciences

Rizatriptin Benzoate

CNS

Merck

Maxalt - MLT

NA

15-Oct

Jubilant Life Sciences

Memantine Hydrochloride

CNS

Forest Labs

Namenda

US$ 1.1 billion

15-Oct

Jubilant Life Sciences

Indomethacin

Anti-Inflammatory

Iroko Pharma

Tivorbex

NA

15-Nov

Jubilant Life Sciences

Paroxitine Hydrochloride

Anti-depressant

Apotex Technologies

Paxil

NA

15-Dec

Jubilant Life Sciences

Citalopram Hydrobromide

Anti-depressant

Forest Labs

Celexa

NA

15-Dec

Jubilant Life Sciences

Paroxetine

Anti-Depressant

Apotex

Paxil

NA

15-Apr

Lupin

Memantine Hydrochloride

CNS

Forest Labs

Namenda

US$ 1.1 billion

15-Apr

Lupin

Quinine Sulfate

Anti-malaria

Mutual Pharm Co Inc

Qualaquin

US$ 31.9 million

15-May

Lupin

Azithromycin

Anti-infective

Pfizer

Zithromax

NA

15-May

Lupin

Moxifloxacin Hydrochloride

Anti-Bacterial

Bayer Healthcare

Avelox

US$ 400 million

15-Jun

Lupin

Amlodipine Besylate, Valsartan and Hydrochlorothiazide Anti-hypertensive

Novartis

Exforge HCT

US$ 320 million

15-Jun

Lupin

Celecoxib

Anti-Inflammatory

GD Searle

Celebrex

US$ 2.44 billion

15-Jun

Lupin

Desvenlafaxine Succinate

Anti-Depressant

Wyeth Pharms

Pristiq

US$ 600 million

15-Jul

Lupin

Calcium Acetate

Kidney Disease

Fresenius Medical

Phoslo

NA

15-Jul

Lupin

Repaglinide and Metformin Hydrochloride

Anti-Diabetic

Novo Nordisk

Prandimet

US$ 200 million

15-Aug

Lupin

Bekyree

Gynecolgy

Organon USA

Cyclessa

US$ 22.5 million

15-Aug

Lupin

Fenofibrate

CVS

Skyepharma

Triglide

US$ 156 million

15-Aug

Lupin

Diclofenac Sodium

Anti-Inflammatory

Nuvo Res Inc

Pennsaid

US$ 13.3 million

15-Aug

Lupin

Omeprazole

Gastro Intestinal

Astrazeneca

Prilosec

US$ 185 million

15-Sep

Lupin

Clarithromycin

Antibiotic

Abbvie

Biaxin

NA

15-Oct

Lupin

Donepezil Hydrochloride

CNS

Eisai Inc.

Aricept

US$ 52.3 million

15-Oct

Lupin

Blisovi 24 FE

Sex-stimulant

Warner Chilcott

Estrostep 21

NA

15-Nov

Lupin

Ethinyl Estradiol; Norethindrone Acetate

Contraceptive

Warner Chilcott LLC

Estrostep

NA

15-Nov

Lupin

Levonorgestrel ; Ethinyl Estradiol

Oral Contraceptive

Teva

Seasonale

US$81 million

16-Mar

Lupin

Ethinyl Estradiol; Norethindrone

Contraceptive

Warner Chilcott

Estrostep

US$ 38.6 million

16-Mar

Lupin

Ethinyl Estradiol; Levonorgestrel

Contraceptive

Wyeth Pharms

Alesse

US$ 6.4 million

15-Dec

Lupin

Ethinyl Estradiol; Norethindrone Acetate

Oral-Contraceptive

Warner Chilcott

Femhrt

US$ 39.9 million

15-Dec

Lupin

Potassium Chloride

CVS

Apothecon

Klotrix

US$ 85.6 million

15-Apr

Natco Pharma

Alprazolam

CNS

UCB Inc

Niravam

NA

16-Jan

Natco Pharma

Lansoprazole

Anti-ulcer

Takeda Pharms

Prevacid

NA

15-Apr

Strides Acrolab

Polyetylene Glycol 3350; Potassium Chloride; Sodium B Colonoscopy

Braintree

Nulytely

US$ 20 million

15-May

Strides Acrolab

Lamivudine and Zidovudine

Anti-retroviral

ViV Healthcare

Combivir

US$ 295 million

15-Jul

Strides Acrolab

Benzonatate

Non-narcotic Cough medPfizer

Tessalon

US$ 40 million

15-Nov

Strides Acrolab

Dutasteride

Nephrology

Glaxo Smith Kline

Avodart

US$ 467 million

15-Apr

Sun Pharma

Oxymorphone Hydrochloride

Pain

Endo Pharms

Opana

US$ 25 million

15-Jun

Sun Pharma

Donepezil Hydrochloride

CNS

Eisai Inc

Aricept

US$ 2.5 billion

15-Jun

Sun Pharma

Levocetirizine Dihydrochloride

Anti-histamine

UCB Inc

Xyzal

US$ 231 million

15-Aug

Sun Pharma

Tetrabanazine

Pain Management

Valeant Pharms

Xenazine

NA

15-Sep

Sun Pharma

Dexmethylphenidate Hydrochloride

CNS

Novartis

Focalin

US$ 683 million

15-Nov

Sun Pharma

Risedronate Sodium

Osteoporosis

Warner Chilcott LLC

Actonel

US$ 180 million

15-Dec

Sun Pharma

Imatinib Mesylate

Anti-Cancer

Novartis

Gleevec

US$ 2.5 billion

Source: Company, ICICIdirect.com Research

ICICI Securities Ltd. | Retail Equity Research

Page 34

Exhibit 30: USFDA approvals for companies under I-Direct coverage in FY16
Date

Company

Drug Name

Therapeutic Area

Innovator company

Generic Version of

Market Size

16-Jan

Sun Pharma

Minocycline Hydrochloride

Anti-biotic

Medicis

Solodyn

US$750 million

16-Jan

Sun Pharma

Buprenorphine Hydrochloride

Anti-pain

Endo Pharms

Belbuca

NA

16-Feb

Sun Pharma

Nitrofurantoin

Antibiotic

Alvogen

Macrodantin

NA

15-Jun

Taro Pharma

Desloratadine

Anti-Biotic

Schering Plough

Clarinex

US$ 212 million

15-Jul

Taro Pharma

Loratadine

Anti-histamine

Bayer Healthcare

Clartin

US$ 301 million

16-Jan

Taro Pharma

Naftifine Hydrochloride

Anti-fungal

Merz Pharms

Naftin

NA

16-Mar

Taro Pharma

Oxiconazole Nitrate

Antiinfective

Fougera Pharma

Oxistat

NA

15-Apr

Torrent Pharma

Aripiprazole

CNS

15-Jun

Torrent Pharma

Amlodipine Besylate, Valsartan and Hydrochlorothiazide Anti-hypertensive

15-Aug

Torrent Pharma

Tolterodine Tartrate

15-Oct

Torrent Pharma

Esomeprazole Magnesium

15-Oct

Torrent Pharma

Memantine Hydrochloride

CNS

15-Dec

Torrent Pharms

Celecoxib

Anti-Inflammatory

GD Searle

Celebrex

US$ 2.44 billion

15-Oct

Unichem Labs

Memantine Hydrochloride

CNS

Forest Labs

Namenda

US$ 1.1 billion

Otsuka

Abilify

US$ 7.8 billion

Novartis

Exforge HCT

US$ 320 million

Nephralogy

Pharmacia & UpJohn

Detrol LA

US$ 571.5 million

GI

Astrazeneca

Nexium

US$ 7.3 billion

Forest Labs

Namenda

US$ 1.1 billion

15-Oct

Unichem Labs

Montelukast Sodium

Anti-asthama

Merck

Singulair

US$ 3.5 billion

16-Jan

Unichem Labs

Alfuzosin Hydrochloride

Prostatic Hyperplasia

Covis Pharma Sarl

Uroxatral

NA

16-Mar

Unichem Labs

Quetiapine Fumarate

CNS

Astrazeneca

Seroquel

NA

15-Dec

Unichem Labs

Irbesartan

CVS

Sanofi Aventis

Avapro

US$ 1.23 billion

Source: Company, ICICIdirect.com Research

ICICI Securities Ltd. | Retail Equity Research

Page 35

Exhibit 31: Tentative approvals for companies under I-Direct coverage in FY16
Date

Company

Drug Name

Therapeutic Area

Innovator company

Generic Version of

Market Size

15-Oct

Ajanta Pharma

Irbesartan

Anti-Hypertensive

Sanofi Aventis

Avapro

US$ 50 million

15-Oct

Ajanta Pharma

Omeprazole; Sodium Bicarbonate

GI

Santarus

Zegerid

NA

16-Jan

Ajanta Pharma

Sildenafil Citrate

Harmonal

Pfizer

Revatio

US$ 300 million

15-Jun

Alembic Pharma

Celecoxib

Anti-Inflammatory

GD Searle

Celebrex

US$ 2.44 billion

16-Mar

Alembic Pharma

Olmesartan Medoxomil

CVS

Daiichi Sankyo

Benicar

NA

15-Jul

Aurobindo Pharma

Sildenafil Citrate

Harmonal

Pfizer

Revatio

US$ 300 million

15-Oct

Aurobindo Pharma

Tadalafil

CVS

Eli Lilly

Adcirca

NA

15-Nov

Aurobindo Pharma

Palonosetron Hydrochloride

Anti-Nausiatic

Helsinn Hlthcare

Aloxi

NA

15-Dec

Aurobindo Pharma

Esomeprazole Magnesium

GI

Astrazeneca Pharma

Nexium

US$ 7.3 billion

15-Dec

Aurobindo Pharma

Bivalirudin

CVS

The Medicines Co.

Angiomax

NA

16-Jan

Aurobindo Pharma

Prasugrel

CVS

Eli Lilly

Effient

US$ 522 million

16-Jan

Aurobindo Pharma

Saxagliptin

Anti-diabetic

Astrazeneca

Onglyza

US$ 820 million

16-Feb

Aurobindo Pharma

Pitavastatin

CVS

Kowa

Livalo

NA

16-Feb

Aurobindo Pharma

Ritonavir

HIV

Abbvie

Norvir

US$ 400 million

16-Mar

Cadila Healthcare

Clofarabine

Anti-cancer

Genzyme

Clolar

NA

15-May

Cipla

Lopinavir and Ritonavir

Anti-Retroviral

Abbott Labs

Kaletra

NA

15-Jun

Cipla

Nevirapine

Anti-retroviral

Boehringer Ingelheim

Viramune

NA

15-Dec

Dr. Reddy's Labs

Fesoterodine Fumarate

Urology

Pfizer

Toviaz

US$ 159 million

16-Jan

Dr. Reddy's Labs

Doxycycline

Antibiotic

Dr. Reddy's Labs

Zenavod

NA

15-Apr

Glenmark

Calcipotriene

Vitamins

Leo Pharma

Dovonex

US$ 92.8 million

15-May

Glenmark Pharma

Rufinamide

Anti-Epilepsy

Eisai

Banzel

US$ 121.8 million

15-Oct

Glenmark Pharma

Lacosamide

Epilepsy

UCB Inc

Vimpat

US$ 365 million

15-Dec

Glenmark Pharma

Dronedarone Hydrochloride

CVS

Sanofi Aventis

Multaq

US$ 425.7 million

16-Feb

Glenmark Pharma

Azelaic Acid

Dermatology

Allergan

Azelex

NA

16-Mar

Glenmark Pharma

Lacosamide

Epilepsy

UCB Inc

Vimpat

US$ 365 million

15-Dec

Jubilant Life Sciences Olmesartan Medoxomil

CVS

Daiichi Sankyo

Benicar

NA

15-Apr

Lupin

Fesoterodine Fumarate

Urology

Pfizer

Toviaz

US$ 159 million

15-Oct

Lupin

Milnacipran Hydrochloride

CNS

Forest Labs

Fetzima

NA

16-Jan

Lupin

Lurasidone Hydrochloride

CNS

Sunovion Pharms

Latuda

US$ 202 million

15-Sep

Natco Pharma

Lapatinib

Anti-Cancer

Glaxo Smith Kline

Tykerb

US$ 362.5 million

15-Sep

Strides Acrolab

Rilpivirine

HIV

Janssen Prods

Edurant

NA

15-Dec

Sun Pharma

Isotretinion

Vitamin

Ranbaxy

Absorica

NA

16-Jan

Sun Pharma

Lacosamide

Epilepsy

UCB Inc

Vimpat

US$ 365 million

16-Jan

Sun Pharma

Lurasidone Hydrochloride

CNS

Sunovion Pharms

Latuda

US$ 202 million

16-Jan

Taro Pharma

Diclofenac Sodium

Anti-Inflammatory

Nuvo Res Inc

Pennsaid

US$ 13.3 million

15-Apr

Torrent Pharma

Rosuvastatin Calcium

Avascular necrosis

IPR

Crestor

US$ 5 billion

15-Jul

Torrent Pharma

Amlodipine and Omlesartan Medoxomil

Bloodpressure

Daiichi Sankyo

Azor

US$ 174 million

15-Oct

Torrent Pharma

Olmesartan Medoxomil

CVS

Daiichi Sankyo

Benicar

NA

16-Feb

Torrent Pharma

Amlodipine; Olmesartan Medoxomil

Bloodpressure

Daiichi Sankyo

Azor

US$ 174 million

15-Jun

Unichem Labs

Alfuzosin Hydrochloride

Prostatic Hyperplasia

Covis Pharma Sarl

Uroxatral

NA

Source: Company, ICICIdirect.com Research

ICICI Securities Ltd. | Retail Equity Research

Page 36

Exhibit 32: Patent Litigations - Indian companies vs. innovators


Month

Innovator

ANDA Filer

Brand Name

API

Used for

Apr-15

Sanofi Aventis

Dr. Reddy's Labs

Jevtana KIT

Cabazitaxel

Prostate Cancer

Apr-15

Sanofi Aventis

Glenmark

Jevtana KIT

Cabazitaxel

Prostate Cancer

Apr-15

Medicis Pharma

Taro Pharma

Zyclara

Imiquimod

Actinic Keratoses

Apr-15

Alcon Research

Wockhardt

Patanol

Olopatadine hydrochloride

Allergic Conjunctivitis

Apr-15

Janssen Products LP

Cipla

Prezista

Darunavir

Anti-Retroviral

Apr-15

Teva Pharma

Dr. Reddy's Labs

Copaxone

Glatiramer

Multiple Sclerosis

Apr-15

Eli Lilly

Lupin

Effient

Prasugrel

CVS

Apr-15

Horizon Pharma

Lupin

Pennsaid

Diclofenac

Osteoporosis

May-15

Apotex Inc.

Lupin

Paxil CR

Paroxitine Hydrochloride

Anti-Anxiety
Acne

May-15

Galderma Labs

Glenmark

Epiduo

Adapalene; Benzoyl Peroxide

May-15

Horizon Pharma

Dr. Reddy's Labs

Vimovo

Esmoprazole Magnesium; Naproxen Osteoporosis

May-15

Merz Pharma

Taro Pharma

Naftin

Naftifine Hydrochloride

May-15

Takeda

Zydus Pharma

Daliresp

Roflumilast

CVS

May-15

Takeda

Strides

Daliresp

Roflumilast

CVS

May-15

Acorda Therapeutics Inc.

Sun Pharma

Ampyra

Dalframpridine

Multiple Sclerosis

May-15

Merck

Lupin

Safyral

Drospiranone; Ethinyl Estradiol; LevomBirth Control

May-15

Kowa

Lupin

Livalo

Pitavastatin Calcium

High Cholestrol

Jun-15

Millenium Pharmaceuticals

Dr. Reddy's Labs

Valcade

Bortezomib

Anti-Cancer

Jun-15

Millenium Pharmaceuticals

Sun Pharma

Valcade

Bortezomib

Anti-Cancer

Jun-15

Reckitt Benckiser LLC

Dr. Reddy's Labs

Mucinex

Guaifenesin; Pseudoephedrine HCl

Bronchial Conjestion

Jul-15

Eli Lilly

Lupin

Axiron

Hypogonadism

Testosterone

Jul-15

Fresenius Medical

Gavis Pharma

Phoslo

Calcium Acetate

Kidney Disease

Jul-15

Alcon Research

Lupin

TravatanZ

Travoprost Ophthalmic solution

Elevated Intraocular pressure

Aug-15

Allergan

Lupin

Namenda

Memantine Hydrochoride

Alzheimer's Disease

Aug-15

Galderma Labs

Taro Pharma

Epiduo

Adapalene & Benzoyl peroxide

Acne

Sep-15

Jazz Pharma

Lupin

Xyrem

Sodium Oxybate

Narcolepsy

Sep-15

Gilead Sciences Inc.

Lupin

Tamiflu

Oseltamivir

Influenza

Sep-15

Horizon Pharma

Lupin

Pennsaid

Diclofenac

Osteoarthritis

Sep-15

Bayer Pharma

Alembic Pharma

Staxyn

Vardenafil Hydrochloride

Sex Stimulant

Oct-15

Merck

Lupin

Beyaz

Drospirenone

Birth control

Oct-15

Salix Pharmaceuticals, Inc.

Taro Pharma

Moviprep

Polyethylene glycol electrolyte soln

Gastro Intestinal

Oct-15

Takeda Pharma

Aurobindo

Prevacid

lansoprazole

Stomach ulcers

Oct-15

Janssen Pharma

Aurobindo

Xarelto

Rivaroxaban

Blood Thinner

Oct-15

Novartis Pharma

Natco Pharma

Gleevec

Matinib Mesylate

Anti-cancer

Oct-15

Otsuka Pharma

Zydus Pharma

Abilify

Aripiprazole

Schizophrenia

Oct-15

AstraZeneca

Alembic Pharma

Brilinta

Ticagrelor

CVS

Nov-15

AstraZeneca

InvaGen Pharma

Brilinta

Ticagrelor

CVS

Nov-15

Novartis Pharma

Dr. Reddy's Labs

Exelon Patch

Rivastigmine

Dementia

Nov-15

Allergan

Aurobindo Pharma

Acular LS

Ketorolactromethamine

Ocular Pain

Nov-15

Shire Pharma

Lupin

Lialda

Mesalamine

Ulcerative Colitis

Nov-15

Dexcel Pharma

Sun Pharma

Omeprazole

Omeprazole

GI

Nov-15

Dexcel Pharma

Dr. Reddy's Labs

Omeprazole

Omeprazole

GI

Nov-15

Cephalon Inc.

Aurobindo Pharma

Nuvigili

Modafinil

CNS

Nov-15

Cosmo Techs

Lupin

Uceris

Budesonide

GI

Nov-15

Pfizer

Dr. Reddy's Labs

Toviaz

Fesoterodine

Urotherapy

Fungal Infection

ssss

Source: Bloomberg, ICICIdirect.com Research

ICICI Securities Ltd. | Retail Equity Research

Page 37

Exhibit 33: Patent litigations - Indian companies vs. innovators


Month

Innovator

ANDA Filer

Brand Name

API

Used for

Nov-15

Vanda Pharma

Lupin

Fanapt

Iloperidone

Schizophrenia

Nov-15

Forest Labs

InvaGen Pharma

Viibryd

Vilazodone

Anti-depressant

Nov-15

Jazz Pharma

Sun Pharma

Xyrem

Gamma-hydroxybutyric acid

CNS

Nov-15

Otsuka Pharma

Alkem Labs

Abilify

Aripiprazole

Schizophrenia

Nov-15

Symed Labs

Glenmark Pharma

Zyvox

Linezolid

Anti-Infective

Dec-15

UCB Inc.

InvaGen Pharma

Zyrtec-D

Cetirizine

Respiratory

Dec-15

Unimed Pharma

Dr. Reddy's Labs

Androgel

Testosterone

Low Testosterone

Dec-15

Helsinn Healthcare

Dr. Reddy's Labs

Aloxi

Palanosetron

Nausea

Dec-15

Sanofi-Aventis

Glenmark Pharma

Multaq

Dronedarone

Atrial Fibrillation

Dec-15

Otsuka Pharma

Ajanta Pharma

Abilify

Aripiprazole

Schizophrenia

Dec-15

Merz Pharma

Taro Pharma

Naftin

Naftifine Hydrochloride

Fungal Infection

Jan-16

Dow Pharma

Taro Pharma

Onexton

Cindamycin Phosphate and Benzoyl P Acne

Jan-16

Cubist Pharma

Dr. Reddy's Labs

Cubicin

Daptomycin

Antibiotic

Feb-16

Bayer Pharma

InvaGen Pharma

Xarelto

Rivaroxaban

Blood Thinner

Feb-16

Bristol Myers Squibb

Cipla

Reyataz

Atazanavir

HIV

Feb-16

Janssen Products LP

Lupin

Prezista

Darunavir

HIV

Mar-16

Shire Canada

Lupin

Daliresp

Roflumilast

Respiratory

Mar-16

Daiichi Sankyo

Torrent Pharma

Benicar

Olmesartan

Anti-depressant

Source: Bloomberg, ICICIdirect.com Research

ICICI Securities Ltd. | Retail Equity Research

Page 38

ICICIdirect.com coverage universe (Pharma & Hospitals)


Company

I-Direct
Code

CMP
(|)

TP
(|)

Rating

M Cap
(| Cr)

EPS (|)
PE(x)
EV/EBITDA (x)
RoCE (%)
RoE (%)
FY16P FY17E FY18E FY16P FY17E FY18E FY16P FY17E FY18E FY16P FY17E FY18E FY16P FY17E FY18E

Ajanta Pharma

AJAPHA 1500 1,780

Buy

13198.6

45.7

52.4

63.6

32.9

28.6

23.6

22.7

19.3

16.3

43.7

37.9

35.6

34.4

30.0

Apollo Hospitals

APOHOS 1297 1,420 Hold

18049.4

22.2

35.0

49.2

58.4

37.1

26.4

26.6

19.2

15.3

8.2

10.9

13.3

8.9

12.6

15.4

Aurobindo Pharma

AURPHA 726.6 990

42518.4

33.9

37.7

45.1

21.4

19.3

16.1

24.8

22.0

18.5

25.0

24.6

26.4

28.1

24.3

22.9

Alembic Pharma

ALEMPHA 529

Buy

28.2

620

Hold

9970.7

38.2

19.6

28.3

13.9

27.0

18.7

12.6

23.9

17.3

58.0

24.8

29.7

51.5

22.3

26.2

Biocon

BIOCON

545

Hold

14340.0

22.1

28.3

30.5

32.5

25.4

23.5

8.7

7.3

6.0

9.1

10.9

11.1

10.9

12.7

12.5

Cadila Healthcare
Cipla

CADHEA 313 390


CIPLA 485.6 470

Buy
Hold

32079.0
39017.3

15.0
18.8

15.5
19.9

20.6
26.2

21.0
25.9

20.2
24.4

15.2
18.6

14.2
16.6

14.1
14.8

10.8
11.8

27.9
12.1

24.6
13.1

29.5
16.0

28.6
12.7

24.4
12.1

26.3
14.1

Divi's Laboratories

DIVLAB

1110 1,260

Buy

29469.7

41.7

45.8

52.4

26.6

24.3

21.2

19.2

16.9

14.4

30.6

29.1

28.4

25.8

23.6

22.6

Dr Reddy's Labs

DRREDD

2974 3,480

Buy

51274.4

142.1 139.2 174.0

20.9

21.4

17.1

13.1

12.8

10.2

15.1

15.1

18.3

18.9

16.1

16.8

Glenmark Pharma

GLEPHA

858 1,000

Buy

21371.3

32.2

41.4

50.1

26.7

20.7

17.1

17.0

13.9

11.5

16.2

18.8

20.3

21.2

21.7

21.0

Indoco Remedies

INDREM 280.3 365

Buy

2583.0

9.3

15.1

20.4

30.1

18.6

13.8

16.1

11.6

9.2

13.2

19.7

24.4

14.7

20.9

24.2

IPCLAB

455

Hold

6157.3

10.0

24.1

30.4

48.7

20.2

16.0

17.9

11.1

8.9

5.8

12.4

14.5

5.5

12.0

13.3

VAMORG 351.5 405

Buy

5599.4

26.0

41.6

56.1

13.5

8.4

6.3

7.6

6.1

4.8

12.0

15.1

17.8

14.2

18.9

20.6

Buy

66023.2

50.4

66.0

74.1

29.1

22.2

19.8

19.4

13.5

11.8

18.6

22.5

23.1

20.7

22.1

19.9

Ipca Laboratories
Jubilant Life Sciences
Lupin

LUPIN

717

488

1464 1,850

Natco Pharma

NATPHA 507.1 600

Sun Pharma

SUNPHA

Buy

8832.4

8.9

10.9

13.0

56.9

46.3

38.9

30.0

26.9

22.8

16.1

16.4

17.3

12.0

13.0

13.7

743

785

Hold

178773.7

23.4

26.2

31.3

31.7

28.3

23.7

20.8

18.1

15.2

18.6

19.5

20.1

18.0

17.3

17.6

445

23.5

Syngene International

SYNINT

396

Buy

7910.0

8.8

11.1

15.6

43.3

34.2

24.3

26.1

20.5

16.7

19.5

13.3

16.7

20.7

21.2

Torrent Pharma

TORPHA

1344 1,650

Buy

22746.6

115.5

67.8

75.0

11.6

19.8

17.9

8.3

14.2

12.8

51.1

27.0

26.8

57.7

27.0

24.4

Unichem Laboratories

UNILAB

260

Buy

2362.3

12.3

15.5

22.1

21.1

16.7

11.7

14.5

11.6

8.3

13.8

16.2

20.4

11.7

13.4

16.8

310

Source: ICICIdirect.com Research

ICICI Securities Ltd. | Retail Equity Research

Page 39

RATING RATIONALE

ICICIdirect.com endeavours to provide objective opinions and recommendations. ICICIdirect.com assigns


ratings to its stocks according to their notional target price vs. current market price and then categorises them
as Strong Buy, Buy, Add, Reduce and Sell. The performance horizon is two years unless specified and the
notional target price is defined as the analysts' valuation for a stock.
Sector view:
Over weight compared to index
Equal weight compared to index
Under weight compared to index
Index here refers to BSE 500

Pankaj Pandey

Head Research

pankaj.pandey@icicisecurities.com

ICICIdirect.com Research Desk,


ICICI Securities Limited,
1st Floor, Akruti Trade Centre,
Road No 7, MIDC,
Andheri (East)
Mumbai 400 093
research@icicidirect.com

ICICI Securities Ltd. | Retail Equity Research

Page 40

ANALYST CERTIFICATION
We /I, Siddhant Khandekar, CA INTER and Mitesh Shah, MS (finance), Nandan Kamat MBA Research Analysts, authors and the names subscribed to this report, hereby certify that all of the views expressed
in this research report accurately reflect our views about the subject issuer(s) or securities. We also certify that no part of our compensation was, is, or will be directly or indirectly related to the specific
recommendation(s) or view(s) in this report.

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ICICI Securities Ltd. | Retail Equity Research

Page 41

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