8 November 2017
Update
| Sector:
Healthcare
BSE SENSEX
33,371
S&P CNX
10,350
Lupin
CMP: INR861
TP: INR1,000(+16%)
Buy
Goa and Indore plant receives Warning Letter
~1/3
rd
of pending ANDAs from these two facilities
Stock Info
Bloomberg
Equity Shares (m)
52-Week Range (INR)
1, 6, 12 Rel. Per (%)
M.Cap. (INR b)
M.Cap. (USD b)
Avg Val, INRm
Free float (%)
LPC IN
452
1,572/846
-22/-42/-65
385.1
5.8
1,765.2
53.2
No data integrity issue was highlighted in the warning letter. Two key things
highlighted by US FDA in the Warning Letter was – 1) investigation of OOS studies
was not proper; 2) hold time study procedure requires changes
LPC is required to do retrospective OOS and hold time studies to come out of WL
status
~40-50 pending ANDA approvals are from these two facilities. LPC is planning to
initiate site transfer for ~12 pending ANDAs.
Amongst future launches Levothryroxine and Tamiflu are not from these plants.
Financials Snapshot (INR b)
2017 2018E 2019E
Y/E Mar
Net Sales
174.9 160.4 182.3
EBITDA
44.9
34.5
38.3
PAT
25.6
17.0
19.3
EPS (INR)
56.6
37.6
42.7
Gr. (%)
12.4 -33.6
13.7
BV/Sh (INR)
298.9 326.0 358.2
RoE (%)
20.9
12.0
12.5
RoCE (%)
13.3
8.3
8.7
P/E (x)
15.2
22.9
20.1
P/BV (x)
2.9
2.6
2.4
Shareholding pattern (%)
As On
Sep-17 Jun-17 Sep-16
Promoter
46.8
46.7
46.7
DII
12.4
9.8
7.2
FII
27.7
30.9
34.7
Others
13.1
12.6
11.4
FII Includes depository receipts
Stock Performance (1-year)
Lupin
Sensex - Rebased
1,950
1,650
1,350
1,050
750
Warning Letter is a negative surprise:
Lupin announced that Goa and
Pithampur (Unit-2) based formulations plant received import alert. This is a
negative surprise as the company in its 2QFY18 earnings call (few days back)
said that they are expecting full resolution in next two months. Given that
existing business in US is coming under pressure due to new competition in
Glumetza and Fortamet and channel consolidation, new approvals are key to
drive growth and sustain current business.
No data integrity issue but needs to do retrospective studies:
LPC
management mentioned that no data integrity issue was highlighted by US FDA
in WL. LPC is required to do retrospective OOS and hold time studies to come
out of WL status. LPC believes that retrospective studies will have to be done
from Jan 2014. However, LPC will get more clarity regarding this in its meeting
with US FDA. LPC has done retrospective studies for OOS at Goa plant in 2015
and 2016 and can use that data also. LPC believes that the company will be
ready for re-inspection in 6 months. Currently we assume resolution of WL at
these two plants by 2H FY19E (typically WL resolution takes 12-18 months.
Key plants for LPC; early resolution critical:
Out of 158 pending ANDAs, ~40-50
are pending from these two facilities. Out of these ~20-25 approvals were
expected in next 12- 18 months. LPC is planning to initiate site transfer for ~12
key ANDAs. Though Tamiflu and Levothyroxine approval will not get impacted
due to this, key approvals including Ranexa, Toprol XL, Sevelamer and few
other ER products will get stuck due to this. We also expect margins to come
under pressure due to negative operating leverage and remediation cost
related to retrospective studies and consultant cost. LPC does not expect any
supply disruption due to issuance of WL.
Near term pressure to persist; stock factoring most of the negatives:
LPC has
invested ~INR60b on R&D between FY16-18E (much higher than what it
invested in a decade prior to that). GMP compliance is key to monetize this
investment. Though in near term stock will remain under pressure, key
approvals in US and resolution of WL status (expected in 12 months) will help
create value in 12-18 months. We maintain Buy with a TP of INR1,000 @ 20x
1H FY20E PER (vs INR1,215 @21x 1H FY20E PER). We have cut FY19E EPS by
~17% as we build impact of WL at Goa and Indore (Unit-2).
Kumar Saurabh – Research analyst
(Kumar.Saurabh@MotilalOswal.com); +91 22 6129 1519
Ankeet Pandya – Research analyst
(Ankeet.Pandya@MotilalOswal.com)
Motilal Oswal research is available on www.motilaloswal.com/Institutional-Equities, Bloomberg, Thomson Reuters, Factset and S&P Capital.
Investors are advised to refer through important disclosures made at the last page of the Research Report.