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Tuesday, October 25, 2022

Biogen Raises Annual Guidance Despite Q3 Earning Impacted By Biosimilar Competition

 

  • Biogen Inc  posted Q3 sales of $2.51 billion, beating the consensus of $2.47 billion, down 10% Y/Y and 8% at constant currency (CC).
  • Multiple sclerosis revenue, including royalties on sales of Ocrevus, of $1.62 billion decreased by 11% (down 9% CC).
  • Spinraza's revenue of $431 million decreased by 3% at actual currency (increased by 2% at CC).
  • Aduhelm generated sales of $1.6 million in Q3, compared to $0.3 million a year ago.
  • Biosimilars' revenue of $188 million decreased by 7% versus the prior year at actual currency and increased by 4% at constant currency.
  • Multiple sclerosis drug Tysabri sales are down 3.3% to $505.5 million.
  • Adjusted EPS of $4.77 came above the consensus of $4.16.
  • Guidance: Biogen raised FY22 sales guidance to $10-$10.15 billion, up from prior guidance of $9.9-$10.1 billion and the consensus of $10.01 billion.
  • The company expects adjusted EPS of 16.50-$17.15, up from $15.25-$16.75 compared to the consensus of $16.49.
  • The increase in guidance is driven primarily by better-than-expected topline performance and continued cost management.
  • The guidance assumes continued declines in Rituxan revenue due to biosimilar competition and a continued erosion of Tecfidera revenue due to generic entry.

Revelation Biosciences: Encouraging Preclinical Data From Kidney Disease Candidate

 

  • Revelation Biosciences Inc  announced positive results in a preclinical model of acute kidney injury (AKI), a chronic kidney disease (CKD). 
  • Treatment with REVTx-300 significantly reduced renal cortical fibrosis in a dose-dependent manner in the medium and high-dose groups (21.7% reduction and 29.3%, respectively).
  • The reduction was comparable to a known TGF-β inhibitor of fibrosis used as a positive control (38.1% reduction).
  • "These promising preclinical results offer hope of new prophylactic option for preventing the deleterious effects of AKI following multiple types of surgery," said Lakhmir Chawla, M.D. at the Jennifer Moreno Department of Veterans Affairs Medical Center, San Diego, CA, and a leading expert in AKI, "as well as potential new treatment options for active acute kidney injury and chronic kidney disease. I look forward to collaborating with Revelation as REVTx-300 moves through the development process."
  • Revelation will continue evaluating the potential of REVTx-300 in additional preclinical models, including CKD, nonalcoholic steatohepatitis, and myocarditis, to identify optimal dosing conditions, to commence in Q4 2022. 
  • Revelation plans to initiate Phase 1 clinical studies in 1H of 2023.