Biogen’s 3Q Revenues Down 18%

Biogen
3Q Revenues: $2.8 billion (-18%)
3Q Earnings: $318 million (-55%)
YTD Revenues: $8.2 billion (-22%)
YTD Earnings: $1.7 billion (-53%)
Comments: Multiple sclerosis (MS) revenue, including royalties on sales of OCREVUS, were $1.8 billion in the quarter, down 19%. SPINRAZA revenue was $444 million, down 10%.
ADUHELM revenue was $0.3 million. In June 2021 the U.S. FDA granted accelerated approval of ADUHELM, which became commercially available in the U.S. during the second quarter of 2021. TYSABRI sales were $523 million in the quarter. TECFIDERA sales were $498 million. VUMERITY sales were $121 million. AVONEX sales were $301 million. Research and development expenses were $702.4 million in the quarter, compared to $1.1 billion in 3Q20. Biosimilars revenue was $203 million in the quarter, down 2%.
 
Filings
In the third quarter of 2021 Eisai initiated a rolling submission to the FDA of a Biologics License Application (BLA) for lecanemab for the treatment of early AD. The BLA is being submitted under the accelerated approval pathway and is primarily based on clinical, biomarker and safety data from the Phase 2b clinical trial (Study 201) in people with early AD and confirmed amyloid pathology.
 
In the third quarter of 2021 BYOOVIZ (ranibizumab-nuna), a biosimilar referencing LUCENTIS (ranibizumab), was approved in the U.S., the E.U., and the U.K.