Mylan Inc. (MYL) received approval from the US Food and Drug Administration (FDA) for the generic version of Braintree Laboratories’ NuLytely, a laxative. The company is eligible to ship the product immediately, which recorded US sales of about $31 million in 2009.
Following this approval, Mylan’s generic portfolio will be strengthened further. We are also happy to note that in March 2010, the company had entered into an agreement with Takeda Pharmaceutical for two type II diabetes drugs — Actoplus Met and Actos — which recorded 2009 sales of $459 million and $3.4 billion, respectively.
Mylan has received quite a few significant approvals in 2009 including the generic version of Bristol-Myers Squibb’s (BMY) Sinemet for treating Parkinson’s and Takeda Pharmaceuticals’ proton pump inhibitor Prevacid delayed-release (DR) capsules.
The company has also settled its dispute with Pfizer (PFE) related to antifungal drug Vfend (voriconazole), following which it received approval to launch the generic version of the drug.
Mylan received a significant approval in the field of HIV treatment for its subsidiary, Matrix. The company received tentative FDA approval under the President’s Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application (NDA) for a fixed-dose combination of Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate tablets.
Currently, Mylan has 144 Abbreviated New Drug Application (ANDAs) pending FDA approval, representing $96.7 billion in annual brand sales, according to IMS Health. Among these, 39 are potential first-to-file opportunities, representing $19.8 billion in annual brand sales.
Mylan recorded a 14% year-over-year increase in generics revenue during the fourth quarter of 2009. The company has re-affirmed its 2010 EPS guidance of $1.50 to $1.70 and provided a strong outlook for the next few years.
Mylan is expecting to record more than $8.5 billion in revenues in 2013 which represents a top-line CAGR (compound annual growth rate) of 15%, from 2010. In addition, EPS is likely to exceed $2.75 in 2013 representing a CAGR of 20%. We are currently Neutral on the stock.
Read the full analyst report on “MYL”
Read the full analyst report on “BMY”
Read the full analyst report on “PFE”
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