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How Is Biogen’s Tecfidera Positioned in 2019?

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MS revenue performance in the first quarter

In the first quarter, Biogen (BIIB) reported MS (multiple sclerosis) franchise revenue of ~$2.1 billion including Ocrevus royalties, a flat performance on a YoY (year-over-year) basis. However, excluding the impact of Ocrevus, which it codeveloped with Roche Holdings (RHHBY), the company reported a 2% YoY fall in MS revenue in the first quarter.

Ocrevus is proving to be a mixed bag for Biogen, as the royalty payments are coming at the cost of direct competition with the company’s wholly owned MS drugs.

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Tecfidera trends

In the first quarter, Biogen’s leading and highest-earning MS asset, Tecfidera, reported $999 million in revenue, a YoY rise of 1% but a sequential fall of 10%. These revenue changes were driven by fluctuations in channel inventory levels.

According to Biogen’s first-quarter earnings conference call, Tecfidera managed to report an increased share of new as well as total prescriptions in the first quarter. The drug reported a faster rise in its new prescription share than in its total prescription share. The drug also reported double-digit volume growth in larger European markets and Japan but suffered from pricing pressures in certain European countries.

Investors have been worried about the future prospects of Tecfidera since the drug’s 514 patent was challenged by Mylan (MYL) in an inter partes review. While the patent protects Tecfidera from generic erosion until 2028, the fate of the drug will ultimately be determined by the United States Patent and Trademark Office, whose decision is due in 2020.

According to its first-quarter earnings investor presentation, to protect its patient base, Biogen plans to launch another oral MS drug, Vumerity, ahead of the outcome of the Tecfidera review. Vumerity has been accepted for review by the FDA, and the agency’s decision is expected by the fourth quarter of 2019. Vumerity’s composition of matter patent is expected to protect the drug from generic erosion until 2033.

 

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