Teva Pharmaceutical continues to grow

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There's been much discussion about Big Pharma losing drug sales to generics as patents expire. So what about the generics, have they been gaining?

Teva Pharmaceutical Industries Ltd. (TEVA), the largest generic drug maker in the world, indeed reported today that its top and bottom line improved. Excluding charges related to the $7.46 billion acquisition of generic drug developer Barr Pharmaceuticals, Teva said its net income gained 4 percent compared to the same quarter last year. On a per share basis, Teva earned 71 cents, which was actually down 4 percent from last year due to taxes, dilution and more, beating Reuters estimates of 68 cents per share.

On the top line, however, the Israeli maker of generic drugs, missed analyst expectations of $3.37 billion, even as first-quarter revenue rose 22 percent to $3.15 billion. The reason for the miss was mostly due to the stronger dollar. The company also backed its previous financial projections for 2009 and 2010, noting that it expects results for the second half of the current year to be stronger than the first half.

CFO Eyal Deshen said the global economic slowdown would only affect Teva marginally and be offset by customers seeking cheaper generic drugs. Teva execs said the first quarter was expected to be the weakest this year for launches of new products with the fourth quarter the most active.

Which brings to fore the main difference between generics and regular pharma developers, even if Teva is not a pure-play generic company. Still, Teva seeks to find branded drugs, especially blockbuster ones in order to be the first to file with the FDA to seek approval of the generic. Paragraph IV of the Hatch-Waxman Act allows 180 day exclusivity to companies that are the "first-to-file." These first six months are then the most lucrative as the generic only competes with the branded drug, not against other generics.

At April 27, Teva says it had 197 product applications awaiting final clearance by the FDA, including 40 tentative clearances. Collectively, the brand products covered by these applications had annual U.S. sales of over $109 billion. Of these applications, 134 were "Paragraph IV" applications challenging patents of branded products. Teva believes it is the first to file on 84 of the 134 applications, relating to products with annual U.S. branded sales exceeding $53 billion.

While Teva also sells Europe, Asia and Latin America, its North American sales accounted for 62 percent of pharmaceutical sales. Hence the importance.

Indeed, it seems analysts generally expect a solid remainder of 2009 as the Barr integration gains traction. Teva's vertical integration and geographic reach are also drivers for solid performance. But analysts mainly expect the company to increase its already extensive product offering and its patent challenge portfolio.
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