Ranbaxy Labs Ohm clearance in line; Hanmi launches Nexium equivalent
Ranbaxy's Ohm Labs facility has received an Establishment
Inspection Report (EIR) from the US-FDA. This establishes
clearance of the previously unresolved 483 at this facility
n All other US-FDA facilities such as Paonta Sahib, Dewas and
Mohali are still under import alert and consent decree
n The possibilities of pending FTFs like Diovan, Valcyte and
Nexium getting monetized remains alive but is contingent on
the timely approvals of site transfers from the US-FDA
n We maintain our TP of Rs308 (base business at 18x CY14E
EPS and Rs55 for FTFs NPV) is based on an assumption that
Ranbaxy would be able to monetize all key FTFs in CY14E.
Ohm Labs clearance inline with base case hypothesis
Ranbaxy's Ohm facility has received an Establishment Inspection Report (EIR) for its Dec’12 inspections. This establishes clearance of the previously unresolved ‘Form 483’
at this facility. An EIR indicates satisfactory resolution of issues related to good
Relative price chart
manufacturing practices (GMP) raised by US-FDA. We see this as a breather for an
otherwise troubled US market operations for Ranbaxy as Ohm Labs is the only facilty,
which is allowed to continue supplies in US market. All other US-FDA facilities viz
Paonta Sahib, Dewas and Mohali are still under import alert and consent decree.
FTFs likely to go through; built into our estimates
The possibilities of pending FTFs like Diovan, Valcyte and Nexium getting monetized
remains alive but is contingent on the timely approvals of site transfers from the US-
FDA. Although we expect FTFs to be monetized we would like to highlight that with Ohm Labs being the only US FDA approved facility and it being run at full capacity today,
incremental launches from this facility might lead to slowdown / decline in base business
for the company. We would also like to highlight that a clearance of this facility is in line
with our expectations and is henced priced into our Target price. However, it being a
sentimental boost to the stock we advise long-term investors to use this as an exit
Hanmi launches Nexium’s modified salt Esomeprazole Strontium; Risk to
In another development relevant to Ranbaxy, Hanmi's Pharma’s injunction on Nexium
equivalent launch has been uplifted by the court. Hanmi has done an “At Risk” launch of
the drug in the US market in the month of September. Although not a direct substitution for Nexium, we believe it could lead to some declines in the sales of Nexium before
Shareholding Pattern (%)
Ranbaxy’s launch of the generic. Hanmi expects the drug to generate sales of ~$15mn
Sep'13 Jun'13 Mar'13
for them in CY13. We believe Hanmi’s drug might be able to take upto 10% of Nexium
share in the market. Hanmi is marketing the product under the brand of "Esomeprazole
strontium delayed release capsule" with a local partner, Amneal Pharmaceuticals.
Our Take: We reiterate that our Target Price of Rs308 is based on an assumption that
Ranbaxy would be able to monetize all key FTFs in CY14E. FTF opportunities NPV
comes to Rs. 55 a share. We value base business at 18x CY14E EPS of Rs14.
Financial Snapshot (Consolidated) Ashish Rathi Sales (Core) (Rs) % chg Krishnanath Munde Key Financials (Consolidated) Income Statement Balance Sheet Y/E Dec (Rsmn) Y/E Dec (Rsmn) Net Sales 112,895 160,048 Expenditure 102,271 118,789 Net worth Minority Interest Loan Funds EBITDA margin (%) 14.4 14.5 9.4 25.8 Total Liabilities 88,475 103,747 99,649 123,043 EBIT margin (%) 10.6 11.9 6.6 23.7 Net block Other Assets Current Assets 105,166 110,936 Adjusted PAT Net Margin (%) 10.4 10.5 5.1 18.5 Current liabilities Adj. PAT After JVs/Ass/MI Reported PAT Net current assets PAT after MI Total Assets 88,475 103,747 99,649 123,043 Cash Flow Key Ratios Y/E Dec (Rsmn) PBT (Ex-Other income) Profitability (%) Operating Cashflow Per Share Data (Rs) Free Cash Flow Investing Cashflow Valuations (x) Financing Cashflow Gearing Ratio (x) Net chg in cash Closing cash position Emkay Global Financial Services Ltd.
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