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Aurobindo Pharma
BSE SENSEX S&P CNX
40,359 11,914 CMP: INR429 TP: INR500 (+17%) Buy
Deficiency in injectables manufacturing controls
Robust CAPA required to resolve issues
th th
The USFDA inspected Aurobindo Pharma’s (ARBP) Unit 4 from 4 -13 Nov’19 and
issued form 483 with 14 observations.
Observations are largely related to deficiencies in studies and monitoring conditions
Stock Info necessary for aseptic processing/injectable facility. It would take 4-6 months of
Bloomberg ARBP IN enhanced efforts to resolve the issues, in our view. Unit 4 accounts for 7-8% of US
Equity Shares (m) 586 sales and has 47 ANDAs pending for approval.
M.Cap.(INRb)/(USDb) 251.2 / 3.5 Despite intensifying regulatory headwinds over the past 8-9 months, ARBP has been
52-Week Range (INR) 838 / 390 able to maintain growth momentum in US generics (+27% YoY in 1HFY20) on the back
1, 6, 12 Rel. Per (%) -13/-39/-61 of new launches and acquisitions. Further, it has a healthy pipeline of 153 ANDAs
12M Avg Val (INR M) 1994 pending for approval in US generics. Separately, EU business profitability is on track
Free float (%) 48.1 owing to its foray into newer markets and shift in product manufacturing to India.
We value ARBP at 8x 12M forward earnings and arrive at a target price of INR500.
Financials Snapshot (INR b) Maintain Buy.
Y/E Mar 2019 2020E 2021E Highlights of Unit 4 form 483
Net Sales 195.6 236.4 296.6 The USFDA inspected Unit 4 as part of cGMP compliance and thereafter issued
EBITDA 40.2 49.6 63.2 form 483 with 14 observations (this site has successfully closed inspection six times
PAT 25.3 27.5 36.1 in the past). The inspector observed deficiencies in media fill studies representing
EPS (INR) 43.2 47.0 61.7 the manufacturing process. Other notable observations were (a) sampling plan not
Gr. (%) 1.1 8.9 31.3 representing worst-case activities and (b) deficiency in systems for maintaining any
BV/Sh (INR) 237.1 281.0 340.2 equipment used to control aseptic conditions. All these observations showed
RoE (%) 19.8 18.1 19.9 deficiency in the assuring aseptic processes in the manufacture of sterile products.
RoCE (%) 14.4 12.1 13.3 A robust response followed by the implementation of CAPA would be required to
P/E (x) 9.9 9.1 6.9 resolve these issues within the 3-6 month timeframe. The USFDA also indicated (a)
P/BV (x) 1.8 1.5 1.3 deviations in sterility testing, (b) higher number of days taken to submit field alert
report, (c) need for comprehensive review of RM, (d) deficiency in investigation of
Shareholding pattern (%) excursions, (e) the lack of evaluation of alarmed events, (f) insufficient
As On Sep-19 Jun-19 Sep-18
documentation, (g) inadequate training and (h) deficiency in design document.
Promoter 51.9 51.9 51.9
DII 13.0 13.3 15.0 Regulatory risk has intensified over past one year
FII 22.0 22.0 19.1 Over the past one year, eight sites have been inspected by the USFDA. Units 1 and
Others 13.2 12.9 14.0
11 have been classified as Official Action Indicated (OAI) and Unit 9 has been issued
FII Includes depository receipts a warning letter recently. Unit 7 is issued form 483 with seven observations. Units 5
Stock Performance (1-year)
and 8 were issued form 483 with four observations each.
Aurobindo Pharma
Sensex - Rebased
Unit-4 contributes ~7-8% of US sales
975 Auromedics comprises injectables from Unit 4, Eugia, Unit 12, Unit 16 and
825 Auronext. It formed ~19% of US sales at end-2QFY20. Excluding sales from Eugia,
675 Units 12/16 and Auronext, Unit 4 would form ~7-8% of USD1.5b US annual sales.
525 Unit 4 has 63 ANDAs approved till date and 47 await final approval.
375
Valuation and view
Nov-18
Nov-19
May-19
Aug-19
Feb-19
Regulatory risk has increased with escalation to OAI/WL at a few sites. However,
US generics growth for ARBP is improving due to new launches/acquisitions.
Further, EU (30% of sales) is penetrating into newer markets and improving
margins by shifting manufacturing to India. We value ARBP at 8x 12MF earnings
(40% discount to three-year average) and arrive at a TP of INR500. Maintain Buy.
Tushar Manudhane – Research analyst (Tushar.Manudhane@MotilalOswal.com); +91 022 6129 1536
Hitakshi Chandrani – Research analyst (Hitakshi.Chandrani@motilaloswal.com); +91 22 6129 1557
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.
Aurobindo Pharma
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Aurobindo Pharma
Gross Block 41,066 53,821 41,312 53,650 70,719 97,987 144,987 159,987
Less: Accum. Deprn. 14,613 17,405 3,455 7,168 11,843 18,298 29,232 42,803
Net Fixed Assets 26,453 36,416 37,856 46,482 58,876 79,689 115,755 117,183
Goodwill on Consolidation 764 640 4,063 4,063 8,165 8,325 18,825 18,825
Capital WIP 3,097 4,196 8,359 12,374 13,995 13,419 13,419 13,419
Total Investments 198 198 1,230 2,459 3,115 3,602 3,602 3,602
Curr. Assets, Loans&Adv. 64,386 87,647 105,631 95,439 125,312 157,676 170,606 206,854
Inventory 23,675 36,113 40,561 43,305 58,584 72,456 83,640 105,672
Account Receivables 26,366 35,392 46,067 35,042 38,721 47,336 56,351 69,879
Cash and Bank Balance 1,786 4,691 8,003 5,135 12,616 19,572 5,615 6,303
Loans and Advances 12,559 11,451 11,001 11,957 15,390 18,312 25,000 25,000
Curr. Liability & Prov. 18,747 36,587 41,909 37,420 47,051 55,275 44,523 53,374
Account Payables 13,512 20,511 24,570 24,883 26,274 26,771 31,898 40,749
Other Current Liabilities 3,877 13,650 15,776 11,415 18,209 26,230 12,000 12,000
Provisions 1,358 2,426 1,563 1,123 2,568 2,274 625 625
Net Current Assets 45,640 51,060 63,722 58,019 78,260 102,400 126,083 153,481
Appl. of Funds 76,151 92,511 115,230 123,397 162,413 207,436 277,684 306,511
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Aurobindo Pharma
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Aurobindo Pharma
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Aurobindo Pharma
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