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
Previous Reco
clearance of the previously unresolved 483 at this facility
n All other US-FDA facilities such as Paonta Sahib, Dewas and
Target Price
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
Price Performance
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,
Stock Details
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.
7th Floor, The Ruby, Senapati Bapat Marg, Dadar - West, Mumbai - 400028. India
Tel: +91 22 66121212 Fax: +91 22 66121299 Web: www.emkayglobal.com
DISCLAIMER: Emkay Global Financial Services Limited and its affiliates are a full-service, brokerage, investment banking, investment management, and financing group. We along with our affiliates are participants in virtually all securities trading markets in India. Our research professionals provide important input into our investment banking and other business selection processes. Investors may assume that Emkay Global Financial Services Limited and/or its affiliates may seek investment banking or other business from the company or companies that are the subject of this material and that the research professionals who were involved in preparing this material may participate in the solicitation of such business. Our salespeople, traders, and other professionals may provide oral or written market commentary or trading strategies to our clients that reflect opinions that are contrary to the opinions expressed herein, and our proprietary trading and investing businesses may make investment decisions that are inconsistent with the recommendations expressed herein. In reviewing these materials, you should be aware that any or all of the foregoing, among other things, may give rise to real or potential conflicts of interest. Additionally, other important information regarding our relationships with the company or companies that are the subject of this material is provided herein. This report is not directed to, or intended for distribution to or use by, any person or entity who is a citizen or resident of or located in any locality, state, country or other jurisdiction where such distribution, publication, availability or use would be contrary to law or regulation or which would subject Emkay Global Financial Limited or its group companies to any registration or licensing requirement within such jurisdiction. Specifically, this document does not constitute an offer to or solicitation to any U.S. person for the purchase or sale of any financial instrument or as an official confirmation of any transaction to any U.S. person unless otherwise stated, this message should not be construed as official confirmation of any transaction. No part of this document may be distributed in Canada or used by private customers in United Kingdom. All material presented in this report, unless specifically indicated otherwise, is under copyright to Emkay. None of the material, nor its content, nor any copy of it, may be altered in any way, transmitted to, copied or distributed to any other party, without the prior express written permission of Emkay. All trademarks, service marks and logos used in this report are trademarks or registered trademarks of Emkay or its Group Companies. The information contained herein is not intended for publication or distribution or circulation in any manner whatsoever and any unauthorized reading, dissemination, distribution or copying of this communication is prohibited unless otherwise expressly authorized. Please ensure that you have read “Risk Disclosure Document for Capital Market and Derivatives Segments” as prescribed by Securities and Exchange Board of India before investing in Indian Securities Market. In so far as this report includes current or historic information, it is believed to be reliable, although its accuracy and completeness cannot be guaranteed.
www.upmc-biosecurity.org www.upmc-cbn.org Wednesday, 4-29-09 | 11:00 AM FDA Emergency Use Authorizations (EUAs): What Are They and What Do By Brooke Courtney, JD, MPH What Do the Swine Flu EUAs Mean for the Current Outbreak? On April 27, 2009, the U.S. Food and Drug Administration (FDA) issued Emergency Use Authorizations (EUAs) for the swine flu outbreak in response to req
TREATMENT REVIEW Diagnostic and Therapeutic Utility of B-Type Natriuretic Peptide in Patients With Renal Insufficiency and Decompensated Heart Failure Peter A. McCullough, MD, MPH, FACC, FACP, FCCP FAHA,* Kuncheria Joseph, MD,† Vandana S. Mathur, MD‡*Divisions of Cardiology, Nutrition and Preventive Medicine, William Beaumont Hospital, RoyalOak, MI, †Bon Secours Hospital, Venice, FL,