Biogen Surprises Wall Street With This News

Biogen announced on Tuesday that its Alzheimer’s treatment was ready to start the regulatory approval process.
This with third-quarter earnings that came in above expectations had investors cheering, sending shares of the biotech stock soaring.

Biogen and its Japan-based partner Eisai Co. Ltd. announced that its decision to pursue approval of aducanumab, an treatment for early Alzheimer’s diseases was made after the drug met the primary endpoint of a Phase 3 Emerge study. The companies had consulted with the U.S. Food and Drug Administration.

Biogen said results from a Phase 3 Engage study of a subset of patients did not meet its primary endpoint, but supported the findings from the Emerge study.

Shares saw their biggest-ever one-day gain on the news.

“This large dataset represents the first time a Phase 3 study has demonstrated that clearance of aggregated amyloid beta can reduce the clinical decline of Alzheimer’s disease, providing new hope for the medical community, the patients, and their families,” said Anton Porsteinsson, a director at the University of Rochester Alzheimer’s Disease Care, Research and Education Program and principal investigator. “There is tremendous unmet medical need, and the Alzheimer’s disease community has been waiting for this moment.”

Biogen plans to file a Biologics License Application (BLA) for aducanumab in early 2020.

Analyst Yatin Suneja at Guggenheim wrote a note titled, “”Just in Time for Halloween, Aducanumab Has Risen from the Dead.”

Biogen also released third quarter financial results revealing that net income increased to $1.55 billion, or $8.39 a share, from $1.44 billion, or $7.15 a share, in the year-ago period. Excluding non-recurring items, such as acquisition- and divestiture-related costs, adjusted earnings per share rose to $9.17 from $7.40. This was above the FactSet consensus of $8.28.

Revenue saw an increase of 5% to $3.60 billion, above the FactSet consensus of $3.54 billion.

“In addition to the recent news on aducanumab, we made strong progress in our pipeline as we initiated new clinical programs targeting Parkinson’s disease and brain contusion, and we look forward to nine important data readouts by the end of next year,” said Chief Executive Michel Vounatsos. “We continue to believe that our core focus on neuroscience will lead to new innovative treatments for patients and will maximize long-term returns for our shareholders.”

Disclaimer: We have no position in Biogen Inc. (NASDAQ: BIIB) and have not been compensated for this article.