26 November 2015
Dr. Reddy’s Lab
BSE Sensex
25,776
S&P CNX
7,832
Update | Sector: Healthcare
CMP: INR3,388
TP: INR3,500 (+3%)
Downgrade to Neutral
Stock Info
Bloomberg
Equity Shares (m)
M.Cap. (INR b)/(USD b)
52-Week Range (INR)
1, 6, 12 Rel. Per (%)
AvgVal,(INR m)
Free float (%)
Warning letters observations on US FDA website
DRRD IN
170.4
560.1/8.5
4383/3010
-19/-2/1
1,391
74.5
Observations include data integrity and quality control issues at these plants
which increases the probability of warning letter getting converted into import
alert.
Remediation plan to include third party audit which would entail additional cost.
Apart from this corrective measures may lead to supply disruption in near term.
Financial Snapshot (INR Billion)
Y/E Mar
2015 2016E 2017E
Sales
EBITDA
Net Profit
Adj. EPS (INR)
EPS Gr. (%)
BV/Sh. (INR)
RoE (%)
RoCE (%)
P/E (x)
P/BV (x)
148.2 162.4 175.5
33.5
22.2
4.5
19.9
16.9
26.0
5.2
41.9
27.3
22.9
20.3
19.7
21.2
4.3
41.8
27.3
0.0
17.4
17.0
21.2
3.7
FDA released the warning letter given to DRRD on the three plants (US
FDA
Link).
Notably, observations at the three facilities include CGMP deviations and
violations. Concerns cited by FDA include issues related to data integrity and
quality control which enhances the risk of import alert on these plants. The
agency has questioned the effectiveness of the current corporate quality
system and has asked DRRD to take global corrective action.
Key concerns raised by US FDA:
FDA highlighted that the processes
implemented at these facilities do not conform to CGMP. One of the key
observations raised at the Srikakulam facility was that US FDA found existence
of an uncontrolled ‘Custom QC laboratory’. Presence of this lab was unknown to
US FDA. These concerns along with other issues raised by US FDA (see
subsequent pages for detail related to other observations) enhance the risk of
products supplied from these facilities to be adulterated.
Remediation plan would entail additional cost and risk of supply disruption:
FDA has asked DRRD to put in place a remediation plan which should ensure
direct corporate oversight over the quality and operations functions of this
facility. They have recommended that DRRD hire a third-party auditor to assist
DRRD regarding overall compliance with CGMP. We think this will entail
additional cost and time to get the facilities fully FDA complaint.
Lower probability of adverse action at Bachupalli plant:
Though it cannot be
ruled but probability of adverse action at Bachupally plant (which got inspected
by US FDA in Jun-15 with some 483 observations) is low now as it did not
receive warning letter along with above mentioned facilities. This is a key
facility for DRRD as it contributes >50% to current US sales.
Regulatory concerns caps upside potential; Downgrading to Neutral:
Sales
contribution from these facilities to US market is ~10-12% of total sales
(~USD250m). We believe the speed with which DRRD is able to resolve these
issues with the FDA is going to be critical (unlikely before FY18, in our view).
Though long term fundamental remain intact, the stock will remain range
bound in the near term due to regulatory concerns. We downgrade the stock to
Neutral with TP of Rs3,500 (@ 20x 1HFY18E PER) and have cut our FY17/18E
EPS by 11-14%. The cut in EPS is attributed to higher remediation cost and
supply disruptions required to take corrective actions.
130.2 160.0 160.0
653.2 789.8 921.7
Shareholding pattern (%)
As on
Sep-15 Jun-15 Sep-14
Promoter
DII
FII
Others
25.5
5.2
55.0
14.4
25.5
5.9
54.8
13.8
25.5
5.4
55.5
13.7
Note: FII includes depository receipts
Stock Performance (1-year)
Kumar Saurabh
(Kumar.Saurabh@MotilalOswal.com); +91 22 3982 5584
Amey Chalke
(Amey.Chalke@MotilalOswal.com); +91 22 3982 5423
Investors are advised to refer through important disclosures made at the last page of the Research Report, Motilal Oswal
research is available on
www.motilaloswal.com/Institutional-Equities,
Bloomberg, Thomson Reuters, Factset and S&P Capital.