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Pharma & Bio Ingredients
Teva Pharmaceutical Industries Ltd., Jerusalem, reported record results for the fourth quarter and full year.
Net income for the fourth quarter rose nine percent to $305 million. For the year, net income increased 11 percent to .
Net sales for the fourth quarter of 2005 increased six percent over the comparable quarter last year to just more than $1.4 billion. For the full year of 2005, net sales reached $5.3 billion, an increase of nine percent over 2004.
Israel Makov, Teva's president and CEO, commented: "I am proud to report that 2005—a challenging year for our industry—was an excellent year for Teva. In fact, it was a record-breaking year for us, not only financially, but strategically as well. We enhanced our leadership both in the global generics industry overall, and in many specific markets around the world. And our innovative product Copaxone became the leading therapy for multiple sclerosis in the U.S."
Mr. Makov added, "Our acquisition of Ivax will allow us to achieve even more, both financially and strategically. And as our global teams work hard to integrate Ivax into the Teva family, we are becoming even more excited about the unique role we believe Teva can play in the transforming health-care industry."
North American pharmaceutical sales (including Copaxone) accounted for 62 percent of the company's fourth quarter 2005 total pharmaceutical sales, reaching $776 million. A combination of higher Copaxone sales and newly launched generic products, including Azithromycin and Fexofenadine, more than offset erosion of Teva's base business during the quarter. North America generic revenue quarter over quarter remained essentially flat.
Teva's U.S. generic pipeline, including products acquired through the Ivax acquisition, is currently comprised of 160 product applications (including 38 tentative approvals) relating to products with total annual brand sales exceeding $94 billion. Of these product applications, 88 were submitted under Paragraph IV. Teva believes that 49 of these Paragraph IV filings, with total annual brand sales exceeding $37 billion, may be "first to file", thereby potentially providing Teva with periods of exclusivity.
Pharmaceutical sales in Europe accounted for 29 percent of the company's fourth quarter 2005 total pharmaceutical sales and increased 13 percent over the comparable quarter of 2004 to $360 million. This increase was primarily due to sales of products that were not sold in the comparable quarter, including Alendronate in the U.K. and The Netherlands, as well as some newly launched products in the U.K. such as Lansoprazole and Sertraline and higher Copaxone sales.
Global in-market sales of Copaxone reached $323 million in the fourth quarter, an increase of 24 percent over the comparable quarter of 2004. For the full year of 2005, global in-market sales of Copaxone reached $1.176 billion, an increase of 26 percent over 2004. U.S. in-market sales in the fourth quarter of 2005 increased 26 percent over the fourth quarter of 2004 to $220 million. For the full year of 2005, U.S. Copaxone® sales increased 25 percent to $782 million compared to 2004. According to IMS data, Copaxone continued to strengthen its position in the U.S. as market leader reaching an all-time record of 34.3 percent in TRx share and 35.2 percent in NRx share in December 2005.
For the fourth quarter of 2005, in-market sales of Copaxone outside the U.S., mainly in Europe, increased by 19 percent over the comparable quarter of 2004, to $103 million. For the entire year, sales outside the U.S. increased by 27 percent to $394 million.
Azilect®- During the fourth quarter, Azilect was introduced in Norway and Poland, raising to eight the number of EU countries in which the product is now available. In the U.S., Teva continues to work with the FDA to resolve the remaining issues regarding final marketing approval of Azilect in the United States.
API sales, including internal sales to Teva's pharmaceutical businesses, in the fourth quarter totaled $295 million, an increase of 20% from the fourth quarter of 2004. Sales to third parties amounted to $141 million in the fourth quarter of 2005, an increase of 24 percent over the comparable quarter of 2004.
Teva's gross profit margin reached 48.3 percent for the fourth quarter of 2005 and 47.2 percent for the full year of 2005, as compared to 46.6 percent in the fourth quarter of 2004. The quarter to quarter variation reflects new product launches, higher Copaxone sales and a different product mix.
Gross Research and Development (R&D) expenses for the fourth quarter reached $102 million or 7 percent of sales, and grew by 4 percent over the comparable quarter of 2004.
Net R&D expenses (after participations) represented 7 percent of net sales for the fourth quarter of 2005, and grew 6 percent over same period in 2004. The increases in R&D expenditures quarter over quarter primarily reflected increased innovative R&D activities.
