How important is Copaxone to Teva
Revenue 1/5
Copaxone = 21.3% of Teva total revenue in 2013…
- Copaxone reached its global peak sales of $4.3 billion in 2013
- In 2013 Teva, with total revenue over $20 billion, had a generic drug business close to $10 billion and specialty drug sales of $8.4 billion (Copaxone accounted for more than half of the specialty drug business)
Profitability 1/2
…while made 50.8% of Teva’s total profitability in 2013
- Copaxone contributed a segment profitability (gross margin – S&M – R&D) of $3.3 billion, with a very healthy margin of 76%
- Other specialty drugs and generic business had a margin of 32% and 17% respectively
- Teva’s total profitability (gross margin – S&M – R&D) was $6.4 billion in 2013
Two “bad” (for Teva) developments in 2013
Biogen’s Tecfidera approved by FDA, which would become the leading MS drug in 2017
- The United States Food and Drug Administration (FDA) announced on March 27, 2013 that it has approved Tecfidera™ (dimethyl fumarate or DMF, formerly known as BG-12) as a first-line therapy for the long-term treatment of relapsing forms of multiple sclerosis (MS).
- Tecfidera is administered in pill form orally (by mouth) and is the third oral DMT approved for MS. The approved dosage is 240 mg to be taken two-times daily.
- FDA approved labeling
court ruling made first generic launch 15 months earlier than expected
- In July 2013, the Court of Appeals for the Federal Circuit reversed an earlier district court decision backing the Teva Copaxone patent estate through September 1, 2015
- The appellate court struck down some of Teva’s composition patents that were protected until that date, with the effect of allowing a launch as early as May 24, 2014