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Aurobindo Pharma
BSE SENSEX S&P CNX
35,697 10,458 CMP: INR450 TP: INR530 (+18%) Buy
Observations at Unit 12 resolvable on robust CAPA
Minimal risk on future growth as no ANDAs pending for approval from Unit 12
th th
The USFDA inspected Aurobindo Pharma’s (ARBP) Unit 12 from 10 to 21 Feb’20
Stock Info and issued form 483 with six observations. The regulator has pointed out
Bloomberg ARBP IN microbiological contamination, lack of training, inadequate analysis of out-of-
Equity Shares (m) 586 specifications, and deficiency in handling of complaints, among others. We believe
M.Cap.(INRb)/(USDb) 263.6 / 3.7 that these issues are resolvable on undertaking robust actions for 3-6 months.
52-Week Range (INR) 838 / 390 There are no ANDAs pending for approval from this site. Further, most existing
1, 6, 12 Rel. Per (%) -5/-24/-36 products at Unit 12 are also approved to be manufactured in Unit 16. Unit 12
12M Avg Val (INR M) 2084 accounts for 3-4% of US sales as a single-source facility, in our view.
Free float (%) 48.1 We remain positive on ARBP and expect 15% earnings CAGR over FY19-22, led by its
robust ANDA pipeline and addition of the Sandoz business. However, increasing
Financials Snapshot (INR b)
regulatory concerns (primarily after revocation of Unit 4 classification) prompt us to
Y/E MARCH 2020E 2021E 2022E
Sales 233.3 299.8 316.8
cut our P/E multiple to 8x (prior: 9x) and revise our TP to INR530.
EBITDA 48.8 63.9 66.5 Highlights of Unit 12 form 483
Adj. PAT 27.3 37.0 38.2
The USFDA inspected ARBP’s Unit 12 as part of cGMP compliance and issued form
EBIT Margin (%) 16.5 16.6 16.3
Cons. Adj. EPS (INR) 46.6 63.1 65.1
483 with six observations: (1) Inadequate measures to prevent contamination of
EPS Gr. (%) 8.0 35.4 3.2 environment, equipment and product by personnel or environmental condition,
BV/Sh. (INR) 280.6 341.2 402.8 which could potentially affect product quality. Specific remarks were made on flow
Ratios of materials, qualification of clean rooms and procedure to control operator access
Net D:E 0.7 0.6 0.4 to clean rooms. (2) Procedures to prevent microbial contamination not established.
RoE (%) 18.0 20.3 17.5
(3) Lack of education/training. (4) Inadequate root cause analysis for reported out-
RoCE (%) 12.0 13.3 12.3
Payout (%) 5.4 4.0 5.4
of-specifications. (5) Issues with handling of complaints. (6) Non-establishment of
Valuations sensitivity of test methods. We expect these issues to be resolved within 3-6
P/E (x) 9.6 7.1 6.8 months post robust CAPA. Note that this site was last inspected in Mar’18 and
EV/EBITDA (x) 7.6 5.9 5.3 classified as VAI.
Div. Yield (%) 0.6 0.6 0.8 Unit-12 contributes ~3-4% of US sales as single-source facility
FCF Yield (%) -21.9 0.2 10.4
ARBP manufactures penicillin (orals and injectables) at Unit 12. All 20 ANDAs filed
EV/Sales (x) 1.6 1.2 1.1
from this site are already approved (no pending approvals). Further, most existing
Shareholding pattern (%)
products at Unit 12 are also approved to be manufactured at Unit 16. We thus see
As On Dec-19 Sep-19 Dec-18
minimum regulatory risk for ARBP. Unit 12 accounts for 3-4% of US sales as a
Promoter 51.9 51.9 51.9
single-source facility.
DII 13.2 13.0 14.4
FII 21.4 22.0 20.1 Increasing regulatory risk at key sites over past 12-15 months
Others 13.5 13.2 13.6 Over the past one year, nine sites have been inspected by the USFDA. Units 1, 11
FII Includes depository receipts and 7 have been classified as Official Action Indicated (OAI) and Unit 9 has been
Stock Performance (1-year) issued a warning letter recently. Units 5 and 8 were inspected in Oct’19 and
Aurobindo Pharma classified as VAI. Recently, there has been revocation of inspection classification at
Sensex - Rebased Unit 4 and thus we await further clarity from a compliance perspective.
920
780 Valuation and view
640
A strong ANDA pipeline (154 pending for approval), potential synergy benefit post
closure of Sandoz acquisition, and operating leverage for EU business are reasons
500
for our positive stance on ARBP. However, we reduce our P/E multiple to 8x (from
360
9x) to factor in the increasing regulatory risk at sites catering to the US market.
Nov-19
May-19
Aug-19
Feb-19
Feb-20
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Aurobindo Pharma
Story in charts
Exhibit 3: Expect sales CAGR of 17% over FY19-22 Exhibit 4: Sandoz portfolio to boost US business
Formulations (INR b) API (INR b)
US formulations (INR b) YoY growth (%)
37 94.2
35
173
32
34 44.9
30 42.0
29 30 74 29.6
27 25.8 21.3
29
12.3 9.0
2.3
54 96 111 120 135 162 201 265 280 34 48 61 90 117 170
68
FY14 FY15 FY16 FY17 FY18 FY19 FY20E FY21E FY22E FY14 FY15 FY16 FY17 FY18 FY19 FY20E FY21E FY22E
Source: Company, MOFSL Source: Company, MOFSL
Exhibit 5: Margins to improve gradually Exhibit 6: Expect EBITDA CAGR of 25% over FY19-21
Gross Margins (%) EBITDA Margins (%) EBITDA (INR b) EBITDA growth (%)
165.1
57.4 59.1 57.2 57.5 57.6
55.5 54.6 55.8 55.8
FY14 FY15 FY16 FY17 FY18 FY19 FY20E FY21E FY22E FY14 FY15 FY16 FY17 FY18 FY19 FY20E FY21E FY22E
Exhibit 7: R&D expense to remain in similar range Exhibit 8: Expect EPS CAGR of ~15% over FY19-22
R&D expense (INR b) EPS (INR)
4.5 4.3
4.0 4.0 4.0
3.6
3.1 3.0
2.6
2.6 3.2 4.1 5.4 6.7 8.7 9.3 12.0 13.6 22.7 27.0 34.6 39.3 42.7 43.2 46.6 63.1 65.1
FY14 FY15 FY16 FY17 FY18 FY19 FY20E FY21E FY22E FY14 FY15 FY16 FY17 FY18 FY19 FY20E FY21E FY22E
Source: Company, MOFSL Source: Company, MOFSL
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Aurobindo Pharma
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NOTES
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Aurobindo Pharma
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