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NvsUpdated: April 19th, 2010
Attention: NVS has raised guidance for 2010
Monday, April 19th, 2010
Novartis AG (NYSE: NVS)
Forward P/E (April 1st 1yr) :10.89
Recent Developments: Norvatis (NVS) is suffering some short-term patent expiration in 2012 when
Zometa (a $1.3 billion cancer drug) and Diovan (a $5 billion hypertension drug) come off patent protection.
These are no small events and represent $6.3 billion of lost revenue. NVS has implemented a strategy to
transform itself from a big pharma company to a more diversified company by acquiring generic companies
(e.g. Sandoz). Novartis is now the 2nd biggest generic drug company in the world and continues to reap the
benefits of global generic expansion. The biggest question for this undervalued stock is do investors think,
“NVS has positioned themselves well enough to create revenue streams to make up for the $6.3 billion due
to these patent expirations. Novartis was one of the first big pharma companies to venture into the very
lucrative oncology business; they still have great drugs in the marketplace led by Zometa” They also have
several outstanding candidates in development including Rheums, Endos, Oncologists and
Recently Novartis submitted for regulatory approval of Gilenia to the FDA and EMA in December 2009. The FDA granted priority review in February 2010, which reduced the standard 10-month review period to six months (June 2010). However, the FDA has asked for an advisory committee meeting to evaluate the risk/benefit profile of Gilenia since it involves a “new active ingredient”. The meeting, scheduled for Jun
10, 2010 can extend the review process beyond the 6-month period.
The market for MS is small by pharma standards. MS is an inflammatory and neurodegenerative condition that affects almost 2.5 million people globally. However, the market is highly competitive with the presence of products such as Biogen’s Avonex ($2.3 billion in revenues in 2009) and Tysabri ($1.1 billion), Teva’s (NasdaqGS: TEVA - News) Copaxone ($2.8 billion) and Merck KGaA’s Rebif (€1.5 billion).
Scope: Contact medical, sales and distribution executives at leading pharmacy wholesalers and distributors
to who are directly involved in the sales and distribution of all or one of these 3 drugs. Examples include
Diovan, Gleevec, .
Drugs are as follows:
• Diovan - Hypertension
• Zometa - Cancer
• Gleevec - Cancer
Issues: (Quantify changes whenever possible and probe for details and specifics.)
• Ask whether sales/inventory levels/consumer demand for each product are meeting/beating/missing sales
plans/expectations for the current Q (Jan – March)?
o Quantify whenever possible and describe why.
o Strive to detail information by national market in Europe, focusing on the top 5 noted above.
• Ask whether pricing or margins for these products have changed compared to Q1 2009?
o Quantify whenever possible and describe why.
o Strive to detail information by national market in U.S and Europe, focusing on the top 5 noted above.
• Outlook for 2010 for each product by national market?
• Are you aware of any regulatory issues that could impact sales of each product this year? (Explain and
detail expected outcome, or key dates.)
o Are you aware of any competitive issues that could impact sales of each product this year?
o Norvatis has forecasted 60% growth for sales of Diovan globally. How will European markets trend
in 2008 compared to this expectation?
o What are the key sales drivers for each drug for 1H2008 and why? Describe status or situation.
Other Issues we are looking at:
Clinical data commentary on Afinitor,Rheums, Endos, Oncologists and Nephrologistspatients. Have the
patients reached their treatment goals and endpoints. Have they confirmed strong efficacy coupled with
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