Dr Reddy’s Labs
BSE SENSEX
31,892
S&P CNX
9,974
1 September 2017
Update | Sector: Healthcare
CMP: INR2,217
TP: INR2,500 (+13%)
Neutral
Suboxone litigation in favor of DRRD; US FDA approval key
The District Court of Delaware (US) has ruled in favor of Dr. Reddy’s (DRRD) in the
Suboxone litigation. The court found the patents ‘150, ‘514, ‘497 valid and non-infringing.
According to IMS, secondary sales for Suboxone films stood at USD1.7b (primary:
USD850m) in CY16. In August 2016, DRRD had acquired eight ANDAs, including
gSuboxone, from Teva Pharmaceutical. Suboxone Film is indicated for the treatment of
opioid dependence.
Bloomberg
Equity Shares (m)
M.Cap.(INR b)/(USD b)
52-Week Range (INR)
1, 6, 12 Rel. Per (%)
Avg Val, (INR m)
Free float (%)
DRRD IN
170.5
526.3 / 7.8
3395 / 1902
-7/-33/-41
1145
73.2
Financials & Valuations (INR b)
Y/E Mar
2017 2018E
Net Sales
140.8 154.4
EBITDA
24.2
28.9
PAT
12.0
14.5
EPS (INR)
72.6
85.1
Gr. (%)
-45.1
17.3
BV/Sh (INR)
740
792
RoE (%)
9.7
11.3
RoCE (%)
6.4
8.0
P/E (x)
30.5
26.0
P/BV (x)
3.0
2.8
2019E
177.4
38.7
21.4
125.2
47.0
902
14.8
11.1
17.7
2.5
Shareholding pattern (%)
As On
Jun-17 Mar-17 Jun-16
Promoter
26.8
26.8
26.4
DII
11.7
10.6
5.8
FII
31.6
32.4
52.3
Others
29.8
30.3
15.6
FII Includes depository receipts
Stock Performance (1-year)
Dr Reddy's Labs
Sensex - Rebased
3,900
3,400
2,900
2,400
1,900
Could be limited competition product in medium term:
As of now, there only
five generic players with whom patent litigation is ongoing (DRRD, Actavis, Par
Pharmaceuticals, Mylan and Alvogen). According to the June 2016 ruling, Par
and Actavis are infringing patent ‘514 (valid until 2024) – both players will
approach the US Court of Appeals for the Federal Circuit. Hearing on litigation
against Alvogen and Mylan will start from 25-Sep 2017. Indivior expects the
ruling in this case to come by 1QCY18 (by this time, the 30-month stay on
Alvogen/Mylan’s products will also be over). Given that the patent is still valid,
any new player will have to go through a 30-month stay for FDA approval.
Key to watch how sales shifts to buprenorphine monthly depot:
On 31 July
2017, the USFDA accepted Indivior’s new drug application (NDA) for
buprenorphine monthly depot (RBP-6000). The FDA has set a PDUFA target
action date of 30 November 2017, and Indivior expects launch of RBP-6000 by
1QCY18 (expected top-line of USD1b). It would be key to watch that how much
sales shift happens from Suboxone films to RBP-6000. Notably, even though
Suboxone tablets became generic (in 2013), Suboxone films continued to
maintain ~60-61% market share in buprenorphine treatment for opioid
dependence in the US. Given that RBP-6000 depot will have monthly dosage
v/s daily for films, Indivior expects this to be a superior product.
Do not expect launch in next 12 months:
There was a pending Complete
Response Letter (CRL) on DRRD’s gSuboxone, to which the company has already
responded in June-17. It is critical that DRRD resolves issues highlighted by the
USFDA. DRRD has a target action date (TAD) of 4QFY18 for gSuboxone. Indivior
will appeal against the district court judgment in the higher court. Indivior
expects the legal battle to continue for another 12-18 months. DRRD has already
indicated in its 1QFY18 earnings call that it will wait for the outcome of the legal
hearing (will not go for at-risk launch even if the USFDA approves the product).
May not contribute much if all players come to market:
If all the five generic
players come to market and 30-50% market shifts to RBP-600, then annualized
EPS contribution will not be >INR8-10 in the medium term. However, if only 2-3
generic players are able to come to the market and there is minimal impact of
RBP-6000 launch on films, then EPS contribution could be INR25-30.
USFDA remediation key; maintain Neutral:
We believe the stock will remain
range bound until there is more visibility on key launches in the US (incl. Aloxi,
Nuvaring, Suboxone, Copaxone 20 & 40mg). We maintain
Neutral
with a target
price of INR2,500 @ 20x FY19E PER.
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.
Kumar Saurabh-Research analyst
(Kumar.Saurabh@MotilalOswal.com); +91 22 6129 1519
Ankeet Pandya-Research analyst
(Ankeet.Pandya@MotilalOswal.com)